Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-28 @ 2:20 PM
Study NCT ID:
NCT05234632
Status:
TERMINATED
Last Update Posted:
2025-06-06
First Post:
2021-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Rochelle.OHara@smith-nephew.com', 'phone': '+44 1923 477218', 'title': "Dr Rochelle O'Hara", 'organization': 'Smith & Nephew, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events for closed incisions collected 14 days post-surgery with a further 16 days follow-up period, up to 30 days from initial application of treatment. Adverse events for chronic wounds and dehisced surgical wounds were collected up to 28 days during the therapy period with no follow up.', 'eventGroups': [{'id': 'EG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 21, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACUTE KIDNEY INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANAEMIA POST SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLISTER ON RIGHT EDGE OF ADHESIVE STRIP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLISTER TO BELLY BUTTON', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLOOD STAINED SPUTUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BP 106/47- HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEST INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CONGESTIVE DERMATITIS OF THE LOWER LEGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DISTENDED ABDOMEN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DRAIN SITE OOZING PUS AND RED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DRESSING STUCK TO THE WOUND AND CAUSED SOME EXCORIATION TO THE SURROUNDING SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DROWSINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ELEVATED INFLAMMATORY MARKERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ELEVATED WHITE BLOOD CELL COUNT POST-OPERATIVELY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'EXCORIATION TO SURROUNDING SKIN TO WOUND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'EXTENSIVE BRUISING TO OPERATED LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FAINT DAY 9 POST-OPERATIVELY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FALL AT HOME- HIT HEAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FEELING GENERALLY UNWELL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FEELING ROUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FRANK RECTAL BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HAEMATOMA AT WOUND SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HAEMATURIA ON CATHETER REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HB 97', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEADACHES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPOGLYCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ILEOSTOMY LEAK INTO WOUND DRESSING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INFECTED HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LEFT ELBOW PAIN. NUMBNESS TI RING & LITTLE FINGER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOOSE BOWELS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOOSE STOOL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOOSE STOOL INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOW EGFR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOW MAGNESIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOW PHOSPHATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOW POST-OPERATIVE SODIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOW POTASSIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOW SODIUM LEVEL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LOW TEMPERATURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MACERATED WOUND EDGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MELENA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MILD CRAMPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MILD PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MONOCYTES: 0.9 HB: 102 WBC: 14.7 NEUTROPHILS: 11.7 CREATINE: 91 E-GFR/1.73M*2 50', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NONE PRODUCTIVE COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'OEDEMA- ANKLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ON ARRIVAL WAS FOUND TO HAVE 2 X MOISTURE LESIONS TO SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'OOZING DRAIN WOUND SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN AROUND WOUND SITE AFTER REMOVAL OF CLIPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN CENTRAL ABDOMEN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN ON REMOVAL OF DRESSING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN OPERATED SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN OPERATIVE SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN RIGHT SIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN VAS 6-8 IN OPERATED KNEE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAINFUL FOOT WHEN TWISTED ANKLE DURING A FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PANIC ATTACKS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PARTICIPANT FINDING PICO14 DRESSING UNCOMFOTABLE, DISTURBING SLEEP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PAIN FROM COCCYX NOT WOUND SITE AS ADHESIVE STRIPS TOUCH COCCYX (PAIN IN COCCYX FROM PREVIOUS FALL)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PASSED FRESH BLOOD PER RECTUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PATIENT DESCRIBES INTERMITTENT COOLING SENSATION ON FOOT OF OPERATED LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PATIENT HAD COVID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PATIENT PRESENTED AND TREATED FOR ONGOING EXACERBATED COPD SYMPTOMS & SUSPECTED CHEST INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'POOR URINE OUTPUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'POST-OPERATIVE ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'POST-OPERATIVE ITCH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'POSTURAL DROP HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PRESSURE DAMAGE TO THE DORSAL CREASE FROM STOCKING MOVEMENT AND CREASING OVER AREA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RAISED BLOOD SUGAR 9.6', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RAISED C-REACTIVE PROTEIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RAISED CREATININE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RAISED POST-OPERATIVE WHITE BLOOD CELLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RAISED RED BLOOD COUNT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RAISED WHITE BLOOD COUNT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RECTAL BLEED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'REDDEN AREA LEFT HEEL DUE TO PRESSURE, SKIN IS NOT BROKEN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'REDUCED O2 SATURATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SEVERE ITCHING ON SURGICAL SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SKIN IRRITATION UNDER THE BANDAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SKIN RASH FORMED POST-OP, CLUSTERED IN DENSE LINES & AREAS OF SKIN ACROSS RIGHT-SID CHEST & SHOULDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SLIGHT POST-OPERATIVE ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SLUGGISH BOWEL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SMALL BOWEL LOOP OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SMALL BRUISING/DEEP TISSUE INJURY TO LEFT EDGE OF WOUND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SORE NOSE DUE TO NASOJEJUNAL AND NASOGASTRIC TUBE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SUPERFICIAL WOUND DEHISCENE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SWELLING LOWER LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TRAUMA TO WOUND BED ON REMOVAL OF DRESSING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TYPE 7 STOOL- DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINE CONCENTRATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VACANT EPISODE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VASOVAGAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VERY DIZZY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITTED GREEN FLUID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WHITE CELL COUNT ELEVATED POST-OPERATIVELY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WIND LIKE UPPER ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WIND PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WOUND INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ADMITTED TO HOSPITAL WITH A CHEST INFECTION.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PATIENTS GENERAL HEALTH HAS QUICKLY DECLINED AND IS NOW AT END OF LIFE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PATIENT HOSPITALISED WITH CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WOUND INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Delivery of Nominal -80mmHg Negative Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}, {'id': 'OG001', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}, {'id': 'OG002', 'title': 'PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds)', 'description': 'Any wound treated with PICO 14. For closed Surgical incisions this will be for 14 days post surgery and with a 30 day follow up. For chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'measurements': [{'value': '-77.2', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '-74.7', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '-76.2', 'spread': '9.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Delivery of nominal -80mmHg negative pressure over the treatment period was measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery status. This data was summarized to provide the average negative pressure delivery overall and for both closed incisions and chronic/dehisced surgical wounds.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated.'}, {'type': 'PRIMARY', 'title': 'Exudate Management: Occurrence of No Exudate Leaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}, {'id': 'OG001', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}, {'id': 'OG002', 'title': 'PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds)', 'description': 'Any wound treated with PICO 14. For closed Surgical incisions this will be for 14 days post surgery and with a 30 day follow up. For chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 Days', 'description': 'Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 14: Patient Scale Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Observer Scale Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Patient Scale Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Observer Scale Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '7.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 and Day 30', 'description': "The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive scale that is designed for the evaluation of all types of scars by professionals and patients. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale.\n\nEach item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable. The Total Score is provided for both the Patient Scale and Observer Scale at Day 14 \\& Day 30. The Total Score for both scales was calculated by summing up the scores of each of the six items. The Total Score ranged from 6 to 60 with a lower score indicating a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 7: Is Incision Clinically Infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Is Incision Clinically Infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Is Incision Clinically Infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Incidence of Surgical Site Infections (SSI) as defined by The Centers for Disease Control and Prevention (CDC) criteria, for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants with an incision that is clinically infected were categorized as either 'Yes' or 'No' (e.g., Is Incision Clinically Infected: Yes or No).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated.\n\nThe FAS population for this outcome measure includes only participants with Closed Incisions identified as not healed (i.e., not fully closed/epithelialized).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 7: Incision Dehisced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Incision Dehisced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Incision Dehisced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Incidence of Surgical Site Complication (SSC) for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants where dehiscence of incision occurred, were categorized as either 'Yes' or 'No' (e.g., Incision dehisced: Yes or No).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated.\n\nThe FAS population for this outcome measure includes only participants with Closed Incisions identified as not healed (i.e., not fully closed/epithelialized).'}, {'type': 'SECONDARY', 'title': 'Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 7: Healthy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Fragile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Inflamed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Dry and flaky', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Healthy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Fragile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Inflamed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Dry and flaky', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Healthy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Fragile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Inflamed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Dry and flaky', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': 'The clinician assessed the condition of the surrounding skin of closed incisions at Day 7, Day 14, and Day 30. The condition of skin was categorized as the number of participants where any of the following characteristics apply:\n\n* Healthy\n* Fragile\n* Inflamed\n* Erythematous\n* Oedematous\n* Eczematous\n* Macerated\n* Bruising\n* Dry and flaky\n* Other', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Level of Pain - Visual Analog Score (VAS): Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Dressings', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Level of Pain: Dressing Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Dressings', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Level of Pain: During Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Dressings', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Level of Pain: Dressing Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Dressings', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 Days', 'description': 'Level of pain on dressing application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 14 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Dressings', 'denomUnitsSelected': 'Dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction During Wear - Performance: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 7: Overall performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Comfort during wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Noise level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Discreetness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Portability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Overall performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Comfort during wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Noise level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Discreetness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Portability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Overall performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Comfort during wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Noise level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Discreetness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Portability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Patient satisfaction in performance at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following:\n\n* Overall performance\n* Comfort during wear\n* Noise level\n* Discreetness\n* Portability", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 7: Showering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Sleeping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Socializing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Showering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Sleeping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Socializing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Showering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Sleeping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Socializing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 30: Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Patient satisfaction during wear in interference with daily living at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following:\n\n* Showering\n* Sleeping\n* Socializing\n* Working", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Ease of Application and Removal: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Was it easy to apply the dressing', 'categories': [{'title': 'Yes', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Was it easy to remove the dressing', 'categories': [{'title': 'Yes', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 14 days', 'description': 'Ease of application and removal of the PICO 14 dressing for Closed Incisions determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either \'Yes\' or \'No\'.', 'unitOfMeasure': 'dressings', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Dressing Wear Time: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days', 'description': 'Overall dressing wear time in days for Closed Incisions only.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Dressing Conformability: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 14 days', 'description': 'Dressing conformability to the closed incision wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either \'Yes\' or \'No\'.', 'unitOfMeasure': 'dressings', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Number of Dressings Used: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days', 'description': 'Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.', 'unitOfMeasure': 'dressings per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Reason for Dressing Change: Closed Incisions Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Routine dressing change', 'categories': [{'title': 'Yes', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate exudate management', 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Pain/discomfort', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Dressing damaged', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Dressing fell off', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Patient removed dressing', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Event', 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Surgical procedure', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Safety alarm', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Dressing components not in place', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'No vacuum', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 14 days', 'description': "Reason for dressing change for Closed Incisions only. Count of occurrences by dressing were categorized as 'Yes' or 'No':\n\n* Routine dressing change\n* Inadequate exudate management\n* Pain/discomfort\n* Dressing damaged\n* Dressing fell off\n* Patient removed dressing\n* Adverse Event\n* Surgical procedure\n* Safety alarm\n* Dressing components not in place\n* No vacuum\n* other", 'unitOfMeasure': 'dressings', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': "Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 14) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Closed Incisions only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 0: Clinically infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Clinically infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Clinically infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 21: Clinically infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Clinically infected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, Day 7, Day 14, Day 21, and Day 28', 'description': "Count of participants with presence of infection as determined by the clinical signs and symptoms at Day 0, Day 7, Day 14, Day 21, and Day 28 for Chronic and Dehisced Surgical Wounds (i.e., clinically infected: 'Yes' or 'No').", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Screening: Width', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Width', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by size measured by the length and width in centimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '5.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by depth measured in millimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Presence of Necrotic Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Presence of Necrotic Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by number of participants with the presence of necrotic tissue (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Necrotic Tissue Amount', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': '<25% of wound bed covered', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '25% to 50% of wound covered', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '50% to < 75% of wound covered', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '75% to 100% of wound covered', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Necrotic Tissue Amount', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': '<25% of wound bed covered', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '25% to 50% of wound covered', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '50% to < 75% of wound covered', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '75% to 100% of wound covered', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by amount of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* \\<25% of wound bed covered\n* 25% to 50% of wound covered\n* 50% to \\< 75% of wound covered\n* 75% to 100% of wound covered', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds with presence of necrotic tissue only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Type of Necrotic Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'White/grey non-viable tissue', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Non-adherent, yellow slough', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Loosely adherent, yellow slough', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Adherent, soft, black eschar', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Firmly adherent, hard/black eschar', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Type of Necrotic Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'White/grey non-viable tissue', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Non-adherent, yellow slough', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Loosely adherent, yellow slough', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Adherent, soft, black eschar', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Firmly adherent, hard/black eschar', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by type of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* White/grey non-viable tissue\n* Non-adherent, yellow slough\n* Loosely adherent, yellow slough\n* Adherent, soft, black eschar\n* Firmly adherent, hard/black eschar', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds with presence of necrotic tissue only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Granulation Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Skin intact or partial thickness wound', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Bright, beefy red; < 75% & >25% of wound filled', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Pink, &/or dull, dusky red &/or fills <25% of wound', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No granulation tissue present', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Granulation Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Skin intact or partial thickness wound', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Bright, beefy red; < 75% & >25% of wound filled', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Pink, &/or dull, dusky red &/or fills <25% of wound', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No granulation tissue present', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by granulation tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* Skin intact or partial thickness wound\n* Bright, beefy red; 75% to 100% of wound filled \\&/or tissue overgrowth\n* Bright, beefy red; \\< 75% \\& \\>25% of wound filled\n* Pink, \\&/or dull, dusky red \\&/or fills \\<25% of wound\n* No granulation tissue present', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Epithelialization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': '100% wound covered, surface intact', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '75% to < 100% wound covered &/or epithelial tissue extends to > 0.5 cm into wound bed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '50% to < 75% wound covered &/or epithelial tissue extends to < 0.5 cm into wound bed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '25% to < 50% wound covered', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '< 25% wound covered', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Epithelialization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': '100% wound covered, surface intact', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '75% to < 100% wound covered &/or epithelial tissue extends to > 0.5 cm into wound bed', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '50% to < 75% wound covered &/or epithelial tissue extends to < 0.5 cm into wound bed', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '25% to < 50% wound covered', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '< 25% wound covered', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by epithelialization at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* 100% wound covered, surface intact\n* 75% to \\< 100% wound covered \\&/or epithelial tissue extends to \\> 0.5 cm into wound bed\n* 50% to \\< 75% wound covered \\&/or epithelial tissue extends to \\< 0.5 cm into wound bed\n* 25% to \\< 50% wound covered\n* \\< 25% wound covered', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Presence of Exudate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Presence of Exudate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by number of participants with presence of exudate (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Screening: Level of Exudate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Light', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Heavy', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Level of Exudate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Light', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Heavy', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by number of participants level of exudate at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as:\n\n* Light\n* Moderate\n* Heavy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds with exudate present only.'}, {'type': 'SECONDARY', 'title': 'Condition of Peri-Wound Skin Assessed Through Visual Inspection at Day 0, Day 7, Day 14, Day 21, and Day 28 Days: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 0 : Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 : Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 : Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 : Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 : Excoriated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 : Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 : Indurated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 0 : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Excoriated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Indurated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Excoriated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Indurated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Excoriated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Indurated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Erythematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Oedematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Eczematous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Excoriated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Macerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Indurated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, Day 7, Day 14, Day 21, and Day 28', 'description': 'The clinician assessed the condition of the surrounding skin of Chronic and Dehisced Surgical Wounds at Day 0, Day 7, Day 14, Day 21, and Day 28. The condition of skin was categorized as the number of participants where any of the following characteristics apply:\n\n* Normal\n* Erythematous\n* Oedematous\n* Eczematous\n* Excoriated\n* Macerated\n* Indurated\n* Other', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '24.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '31.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.2', 'spread': '22.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.5', 'spread': '24.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Day 14, Day 21, and Day 28', 'description': 'The reference wound area captured at each study visit. Percentage change in area calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.', 'unitOfMeasure': 'percent change in wound area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.8', 'spread': '30.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.3', 'spread': '32.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '30.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.3', 'spread': '24.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Day 14, Day 21, and Day 28', 'description': 'The reference wound volume captured at each study visit. Percentage change in volume calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.', 'unitOfMeasure': 'percent change in wound volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Level of Pain: Dressing Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Level of Pain: During Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Level of Pain: Dressing Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28 days', 'description': 'Level of pain on application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 28 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 14: Overall performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Comfort during wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Noise level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Discreetness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Portability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Overall performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Comfort during wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Noise level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Discreetness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Portability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14 and Day 28', 'description': "Patient satisfaction in performance at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following:\n\n* Overall performance\n* Comfort during wear\n* Noise level\n* Discreetness\n* Portability", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Day 14: Showering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Sleeping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Socializing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14: Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Showering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Sleeping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Socializing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14 and Day 28', 'description': "Patient satisfaction during wear in interference with daily living at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following:\n\n* Showering\n* Sleeping\n* Socializing\n* Working", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Was it easy to apply the dressing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '112', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Was it easy to remove the dressing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '105', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 28 days', 'description': 'Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either \'Yes\' or \'No\'.', 'unitOfMeasure': 'dressings', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28 days', 'description': 'Dressing wear time in days summarized for Chronic and Dehisced Surgical Wounds over the treatment period up to 28 days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Dressing Conformability: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '112', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 28 days', 'description': 'Dressing conformability to the wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either \'Yes\' or \'No\'.', 'unitOfMeasure': 'dressings', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28 days', 'description': 'Dressing change frequency summarized as the number of dressings used per participant for Chronic and Dehisced Surgical Wounds', 'unitOfMeasure': 'dressings per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dressings', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'title': 'Routine dressing change', 'categories': [{'title': 'Yes', 'measurements': [{'value': '84', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate exudate management', 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Pain/discomfort', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Dressing damaged', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Dressing fell off', 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Patient removed dressing', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Event', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}, {'title': 'Surgical procedure', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Safety alarm', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}, {'title': 'Dressing components not in place', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'No vacuum', 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'title': 'Yes', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 28 days', 'description': "Reason for dressing change for Chronic and Dehisced Surgical Wounds only. Count of occurrences by dressing were categorized as 'Yes' or 'No':\n\n* Routine dressing change\n* Inadequate exudate management\n* Pain/discomfort\n* Dressing damaged\n* Dressing fell off\n* Patient removed dressing\n* Adverse Event\n* Surgical procedure\n* Safety alarm\n* Dressing components not in place\n* No vacuum\n* other", 'unitOfMeasure': 'dressings', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dressings', 'denomUnitsSelected': 'dressings', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}, {'type': 'SECONDARY', 'title': 'Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': "Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 28) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated for Chronic and Dehisced Surgical Wounds only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}, {'id': 'FG001', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Participant Withdrawn: Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant tested positive for COVID-19 and is in isolation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn by participant upon experiencing Adverse Event.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Overall, 45 participants were enrolled to the study at 6 sites. There was one (1) screen failure, leaving 44 subjects (25 closed incisions; 19 chronic wounds) receiving PICO 14 NPWT treatment forming the safety analysis set (SAF).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}, {'id': 'BG001', 'title': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.\n\nPICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.6', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '71.3', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '71.5', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who received the study device with available data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-12', 'size': 3838686, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-14T12:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Due to enrolment issues with dehisced and DFU's wounds", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2021-05-28', 'resultsFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-09', 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delivery of Nominal -80mmHg Negative Pressure', 'timeFrame': 'Day 30', 'description': 'Delivery of nominal -80mmHg negative pressure over the treatment period was measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery status. This data was summarized to provide the average negative pressure delivery overall and for both closed incisions and chronic/dehisced surgical wounds.'}, {'measure': 'Exudate Management: Occurrence of No Exudate Leaks', 'timeFrame': 'Up to 30 Days', 'description': 'Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.'}], 'secondaryOutcomes': [{'measure': 'Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only', 'timeFrame': 'Day 14 and Day 30', 'description': "The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive scale that is designed for the evaluation of all types of scars by professionals and patients. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale.\n\nEach item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable. The Total Score is provided for both the Patient Scale and Observer Scale at Day 14 \\& Day 30. The Total Score for both scales was calculated by summing up the scores of each of the six items. The Total Score ranged from 6 to 60 with a lower score indicating a better outcome."}, {'measure': 'Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Incidence of Surgical Site Infections (SSI) as defined by The Centers for Disease Control and Prevention (CDC) criteria, for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants with an incision that is clinically infected were categorized as either 'Yes' or 'No' (e.g., Is Incision Clinically Infected: Yes or No)."}, {'measure': 'Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Incidence of Surgical Site Complication (SSC) for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants where dehiscence of incision occurred, were categorized as either 'Yes' or 'No' (e.g., Incision dehisced: Yes or No)."}, {'measure': 'Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': 'The clinician assessed the condition of the surrounding skin of closed incisions at Day 7, Day 14, and Day 30. The condition of skin was categorized as the number of participants where any of the following characteristics apply:\n\n* Healthy\n* Fragile\n* Inflamed\n* Erythematous\n* Oedematous\n* Eczematous\n* Macerated\n* Bruising\n* Dry and flaky\n* Other'}, {'measure': 'Level of Pain - Visual Analog Score (VAS): Closed Incisions Only', 'timeFrame': 'Up to 14 Days', 'description': 'Level of pain on dressing application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 14 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.'}, {'measure': 'Patient Satisfaction During Wear - Performance: Closed Incisions Only', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Patient satisfaction in performance at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following:\n\n* Overall performance\n* Comfort during wear\n* Noise level\n* Discreetness\n* Portability"}, {'measure': 'Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only', 'timeFrame': 'Day 7, Day 14, and Day 30', 'description': "Patient satisfaction during wear in interference with daily living at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following:\n\n* Showering\n* Sleeping\n* Socializing\n* Working"}, {'measure': 'Ease of Application and Removal: Closed Incisions Only', 'timeFrame': 'Up to 14 days', 'description': 'Ease of application and removal of the PICO 14 dressing for Closed Incisions determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either \'Yes\' or \'No\'.'}, {'measure': 'Dressing Wear Time: Closed Incisions Only', 'timeFrame': 'Up to 14 days', 'description': 'Overall dressing wear time in days for Closed Incisions only.'}, {'measure': 'Dressing Conformability: Closed Incisions Only', 'timeFrame': 'Up to 14 days', 'description': 'Dressing conformability to the closed incision wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either \'Yes\' or \'No\'.'}, {'measure': 'Number of Dressings Used: Closed Incisions Only', 'timeFrame': 'Up to 14 days', 'description': 'Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.'}, {'measure': 'Reason for Dressing Change: Closed Incisions Only', 'timeFrame': 'Up to 14 days', 'description': "Reason for dressing change for Closed Incisions only. Count of occurrences by dressing were categorized as 'Yes' or 'No':\n\n* Routine dressing change\n* Inadequate exudate management\n* Pain/discomfort\n* Dressing damaged\n* Dressing fell off\n* Patient removed dressing\n* Adverse Event\n* Surgical procedure\n* Safety alarm\n* Dressing components not in place\n* No vacuum\n* other"}, {'measure': 'Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only', 'timeFrame': 'Day 14', 'description': "Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 14) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?"}, {'measure': 'Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Day 0, Day 7, Day 14, Day 21, and Day 28', 'description': "Count of participants with presence of infection as determined by the clinical signs and symptoms at Day 0, Day 7, Day 14, Day 21, and Day 28 for Chronic and Dehisced Surgical Wounds (i.e., clinically infected: 'Yes' or 'No')."}, {'measure': 'Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by size measured by the length and width in centimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.'}, {'measure': 'Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by depth measured in millimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.'}, {'measure': 'Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by number of participants with the presence of necrotic tissue (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.'}, {'measure': 'Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by amount of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* \\<25% of wound bed covered\n* 25% to 50% of wound covered\n* 50% to \\< 75% of wound covered\n* 75% to 100% of wound covered'}, {'measure': 'Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by type of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* White/grey non-viable tissue\n* Non-adherent, yellow slough\n* Loosely adherent, yellow slough\n* Adherent, soft, black eschar\n* Firmly adherent, hard/black eschar'}, {'measure': 'Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by granulation tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* Skin intact or partial thickness wound\n* Bright, beefy red; 75% to 100% of wound filled \\&/or tissue overgrowth\n* Bright, beefy red; \\< 75% \\& \\>25% of wound filled\n* Pink, \\&/or dull, dusky red \\&/or fills \\<25% of wound\n* No granulation tissue present'}, {'measure': 'Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by epithelialization at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:\n\n* 100% wound covered, surface intact\n* 75% to \\< 100% wound covered \\&/or epithelial tissue extends to \\> 0.5 cm into wound bed\n* 50% to \\< 75% wound covered \\&/or epithelial tissue extends to \\< 0.5 cm into wound bed\n* 25% to \\< 50% wound covered\n* \\< 25% wound covered'}, {'measure': 'Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by number of participants with presence of exudate (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.'}, {'measure': 'Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Screening and Day 28', 'description': 'Appearance of the wound by number of participants level of exudate at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as:\n\n* Light\n* Moderate\n* Heavy'}, {'measure': 'Condition of Peri-Wound Skin Assessed Through Visual Inspection at Day 0, Day 7, Day 14, Day 21, and Day 28 Days: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Day 0, Day 7, Day 14, Day 21, and Day 28', 'description': 'The clinician assessed the condition of the surrounding skin of Chronic and Dehisced Surgical Wounds at Day 0, Day 7, Day 14, Day 21, and Day 28. The condition of skin was categorized as the number of participants where any of the following characteristics apply:\n\n* Normal\n* Erythematous\n* Oedematous\n* Eczematous\n* Excoriated\n* Macerated\n* Indurated\n* Other'}, {'measure': 'Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Day 7, Day 14, Day 21, and Day 28', 'description': 'The reference wound area captured at each study visit. Percentage change in area calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.'}, {'measure': 'Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Day 7, Day 14, Day 21, and Day 28', 'description': 'The reference wound volume captured at each study visit. Percentage change in volume calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.'}, {'measure': 'Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Up to 28 days', 'description': 'Level of pain on application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 28 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.'}, {'measure': 'Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Day 14 and Day 28', 'description': "Patient satisfaction in performance at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following:\n\n* Overall performance\n* Comfort during wear\n* Noise level\n* Discreetness\n* Portability"}, {'measure': 'Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Day 14 and Day 28', 'description': "Patient satisfaction during wear in interference with daily living at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following:\n\n* Showering\n* Sleeping\n* Socializing\n* Working"}, {'measure': 'Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Up to 28 days', 'description': 'Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either \'Yes\' or \'No\'.'}, {'measure': 'Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Up to 28 days', 'description': 'Dressing wear time in days summarized for Chronic and Dehisced Surgical Wounds over the treatment period up to 28 days.'}, {'measure': 'Dressing Conformability: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Up to 28 days', 'description': 'Dressing conformability to the wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either \'Yes\' or \'No\'.'}, {'measure': 'Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Up to 28 days', 'description': 'Dressing change frequency summarized as the number of dressings used per participant for Chronic and Dehisced Surgical Wounds'}, {'measure': 'Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Up to 28 days', 'description': "Reason for dressing change for Chronic and Dehisced Surgical Wounds only. Count of occurrences by dressing were categorized as 'Yes' or 'No':\n\n* Routine dressing change\n* Inadequate exudate management\n* Pain/discomfort\n* Dressing damaged\n* Dressing fell off\n* Patient removed dressing\n* Adverse Event\n* Surgical procedure\n* Safety alarm\n* Dressing components not in place\n* No vacuum\n* other"}, {'measure': 'Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only', 'timeFrame': 'Day 28', 'description': "Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 28) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Closed incision wounds', 'Chronic wounds', 'PICO'], 'conditions': ['Surgical Incision', 'Ulcer Foot', 'Ulcer Venous', 'Ulcer, Leg', 'Pressure Ulcer', 'Wound Dehiscence']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO.\n\nThe primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Seventy patients with Chronic open wounds (pressure ulcers, venous leg ulcers, diabetes-related foot ulcers, dehisced surgical wounds) and Closed surgical incisions, will be recruited to the study and will receive therapy with PICO 14. There will be a minimum of 10 of each of the following wound type; venous leg ulcers, diabetes-related foot ulcers, pressure ulcers, dehisced surgical wounds and post-operative incisions. The patients will be recruited from up to 7 sites in the United Kingdom, EU, and US, Canada. Sites failing to enroll may be replaced.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must provide written informed consent.\n* Subjects eighteen (18) years of age or older.\n* Willing and able to make all required study visits.\n* Able to follow instructions.\n* Subject is suitable to participate in the study in the opinion of the Investigator.\n\nClosed Incisions ONLY:\n\n* Subject has a suitable, closed surgical incision which the clinician considers is suitable for PICO therapy, where it is expected that the therapy will be applied for up to 14 days.\n* Any closed surgical incision in a patient in which the patient is deemed high risk of developing surgical site infection (SSI) in the opinion of the investigator.\n\nChronic wounds ONLY:\n\n* Patients with any chronic wound\\* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.\n\n * \\*Chronic wound in this study is defined as any wound of less than three months duration that is not healing after 4 weeks of standard care and having addressed the underlying cause.\n\nDehisced surgical wounds ONLY:\n\n* Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.\n\n * \\*Wound dehiscence is a surgical complication in which two sides of a surgical incision separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 days postsurgery and up to a month with more complicated surgeries\n\nExclusion Criteria:\n\n* Contraindications (per the PICO 14 Instructions for use \\[IFU\\]) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films \\[direct contact with incision\\], acrylic adhesives \\[direct contact with skin\\], polyethylene fabrics and super-absorbent powders \\[polyacrylates\\]) within the dressing).\n* Subjects who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.\n* Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.\n* Subjects with skin features (e.g. tattoos, skin colour, preexisting scarring) which in the opinion of the Investigator, will interfere with the study assessments.\n* Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).\n* Subjects who have participated previously in this clinical trial\n* Subjects with a history of poor compliance with medical treatment.\n* Malignant wounds, open abdomen, wounds which have been previously managed with NPWT in the previous four weeks.\n* Pregnancy.\n* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.\n* Presence of infection as determined by the clinical signs and symptoms (International wound infection).'}, 'identificationModule': {'nctId': 'NCT05234632', 'acronym': 'PICO14', 'briefTitle': 'Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds', 'orgStudyIdInfo': {'id': 'PICO14.WND.PRO.2019.03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PICO 14 Closed Incisions', 'description': 'Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.', 'interventionNames': ['Device: PICO 14 single-use Negative Pressure Wound Therapy System']}, {'label': 'PICO 14 Chronic/Dehisced Surgical Wounds', 'description': 'Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.', 'interventionNames': ['Device: PICO 14 single-use Negative Pressure Wound Therapy System']}], 'interventions': [{'name': 'PICO 14 single-use Negative Pressure Wound Therapy System', 'type': 'DEVICE', 'description': 'The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.', 'armGroupLabels': ['PICO 14 Chronic/Dehisced Surgical Wounds', 'PICO 14 Closed Incisions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-70374', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Klinikum der Landeshauptstadt Stuttgart gKAöR', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Margate', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth the Queen Mother Hospital', 'geoPoint': {'lat': 51.38132, 'lon': 1.38617}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Northumbria Healthcare NHS Trust', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham Breast Institute', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'SY10 7AG', 'city': 'Oswestry', 'country': 'United Kingdom', 'facility': 'Robert Jones and Agnes Hunt Orthopaedic Hospital', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}, {'zip': 'PR2 8DW', 'city': 'Preston', 'country': 'United Kingdom', 'facility': 'The Lantern Centre', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'overallOfficials': [{'name': 'Rachel Jahnke', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}