Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-04-18 @ 4:27 PM
Study NCT ID:
NCT01888367
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2013-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kallenby@drreddys.com', 'phone': '609-375-9855', 'title': 'VP, Drug Development', 'organization': "Promius Pharma, LLC, Dr. Reddy's Laboratories"}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The number of culture positive SSIs were too small to draw any conclusions on antibiotic resistance.'}}, 'adverseEventsModule': {'timeFrame': 'From time of surgery until 30 days post-op.', 'description': 'Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.', 'eventGroups': [{'id': 'EG000', 'title': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Antibiotic Gel', 'otherNumAtRisk': 284, 'otherNumAffected': 267, 'seriousNumAtRisk': 284, 'seriousNumAffected': 59}, {'id': 'EG001', 'title': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Placebo Gel', 'otherNumAtRisk': 64, 'otherNumAffected': 61, 'seriousNumAtRisk': 64, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.', 'otherNumAtRisk': 93, 'otherNumAffected': 86, 'seriousNumAtRisk': 93, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 143, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 52, 'numAffected': 52}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Procedural Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anemia Postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Incision Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Postoperative Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 118, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal Distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypoproteinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypochloremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urine Output Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oxygen Saturation Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Amylase Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Incision Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pelvic Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 42, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Pelvic Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneuomia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Clostridium difficile Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hematoma Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Incision Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Splenic Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory 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'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pelvic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Surgical Site Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Antibiotic Gel'}, {'id': 'OG001', 'title': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Placebo Gel'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days of surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Antibiotic Gel'}, {'id': 'OG001', 'title': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Placebo Gel'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.'}], 'classes': [{'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days of surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Creatinine Measurements From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Antibiotic Gel'}, {'id': 'OG001', 'title': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Placebo Gel'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.2', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '-10.2', 'spread': '27.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 4 days of surgery', 'description': 'Change from baseline in micromoles/liter', 'unitOfMeasure': 'micromoles/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were "as treated" so patients randomized to gel but did not receive it in surgery were counted in the SOC group.'}, {'type': 'SECONDARY', 'title': 'Cumulative ASEPSIS Score for Each Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Antibiotic Gel'}, {'id': 'OG001', 'title': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Placebo Gel'}, {'id': 'OG002', 'title': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through post-operative Day 4', 'description': 'Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyses were "as treated" so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Antibiotic Gel'}, {'id': 'FG001', 'title': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Placebo Gel'}, {'id': 'FG002', 'title': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': '30-Day Visit Too Early (< 28 Days)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '445', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Antibiotic Gel'}, {'id': 'BG001', 'title': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.\n\nDFA-02 Placebo Gel'}, {'id': 'BG002', 'title': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '58.8', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '14.7', 'groupId': 'BG002'}, {'value': '59.8', 'spread': '14.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '389', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '445', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 445}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2013-06-25', 'resultsFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-17', 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Surgical Site Infections', 'timeFrame': 'Within 30 days of surgery'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Adverse Events', 'timeFrame': 'Within 30 days of surgery'}, {'measure': 'Change in Serum Creatinine Measurements From Baseline', 'timeFrame': 'Within 4 days of surgery', 'description': 'Change from baseline in micromoles/liter'}, {'measure': 'Cumulative ASEPSIS Score for Each Patient', 'timeFrame': 'Through post-operative Day 4', 'description': 'Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Surgical Site Infections']}, 'descriptionModule': {'briefSummary': 'This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery. patients will be randomized to active or placebo gel in a double-blind manner. The gel will be applied a single time in the incision during closure at the end of surgery. A cohort of patients will also be randomized to standard of care, saline irrigation at prior to skin closure, in an open manner. The efficacy, safety and tolerability of the active gel will be assessed compared to the control group (combined placebo gel and standard of care groups). Patients will be randomized to DFA-02 active gel: placebo gel: standard of care in a 4:1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females 18 years of age or older;\n2. If female, the subject must be postmenopausal, surgically sterilized or, if of child-bearing potential, she must have a negative serum or urine pregnancy test within 48 hours of surgery and agree to use adequate birth control during the study and for 30 days after the administration of study agent;\n3. Body mass index (BMI) ≥ 20;\n4. Scheduled to undergo non-emergent abdominal surgery involving a planned incision of 7 cm or greater;\n5. Willing and able to give informed consent;\n6. Available for evaluation from Baseline until final evaluation at 30 days post-surgery.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to gentamicin, vancomycin, other aminoglycoside antibiotics or the excipients of the study products;\n2. Emergency surgery;\n3. Significant concomitant surgical procedure;\n4. Prior laparotomy within the last 60 days of the planned procedure;\n5. Planned second laparotomy or abdominal surgical procedure within 30 days of the planned first procedure;\n6. Expectation that a surgical drain will be placed in the incision;\n7. Preoperative sepsis, severe sepsis, or septic shock;\n8. Abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason;\n9. Active systemic infection or systemic (oral or intravenous) antibiotic therapy within the 1 week prior to the date of surgery other than specified preoperative antimicrobial prophylaxis;\n10. Requirement for gentamicin or vancomycin preoperative antimicrobial prophylaxis;\n11. Concurrent systemic use of other potentially neurotoxic, nephrotoxic, and/or ototoxic drugs;\n12. Preoperative evaluation suggesting an intra-abdominal process that might preclude full closure of the skin;\n13. Ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer;\n14. History of significant drug or alcohol abuse;\n15. Serum Creatinine \\> 1.8 mg/dL;\n16. Serum Bilirubin \\> 2.5 times upper limit of normal;\n17. Subjects who are immunocompromised including but not limited to systemic corticosteroid use or chemotherapy/radiation during the 30 days prior to surgery, organ transplantation, or HIV infection;\n18. Known history of HIV;\n19. Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability;\n20. Refusal to accept medically indicated blood products;\n21. Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated;\n22. Unable to participate in the study for any reason in the opinion of the Principal Investigator;\n23. Postsurgical life expectancy of less than 30 days;\n24. Expected discharge from the hospital less than 3 days after surgery.'}, 'identificationModule': {'nctId': 'NCT01888367', 'briefTitle': 'Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'A Randomized, Blinded, Placebo and Standard of Care Controlled Efficacy, Safety, and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery', 'orgStudyIdInfo': {'id': 'DFA-02-CD-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DFA-02 Antibiotic Gel', 'description': 'Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.', 'interventionNames': ['Drug: DFA-02 Antibiotic Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DFA-02 Placebo Gel', 'description': 'Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.', 'interventionNames': ['Drug: DFA-02 Placebo Gel']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.'}], 'interventions': [{'name': 'DFA-02 Antibiotic Gel', 'type': 'DRUG', 'armGroupLabels': ['DFA-02 Antibiotic Gel']}, {'name': 'DFA-02 Placebo Gel', 'type': 'DRUG', 'armGroupLabels': ['DFA-02 Placebo Gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Florence', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.79981, 'lon': -87.67725}}, {'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'city': 'Powder Springs', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.85955, 'lon': -84.68382}}, {'city': 'Indianaoplis', 'state': 'Indiana', 'country': 'United States'}, {'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'city': 'Nassau Bay', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.54468, 'lon': -95.09104}}, {'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Elliott Bennett-Guerrero, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duke Clinical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}