Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT00617357
Status:
COMPLETED
Last Update Posted:
2015-12-01
First Post:
2008-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Repair of Infected or Contaminated Hernias
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfranz@lifecell.com', 'phone': '908 947 1100', 'title': 'Dr Michael Franz', 'organization': 'LifeCell'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)', 'eventGroups': [{'id': 'EG000', 'title': 'Strattice', 'otherNumAtRisk': 80, 'otherNumAffected': 20, 'seriousNumAtRisk': 80, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Arteriosclerosis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Cholecyctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Cholecyctitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Clostridium difficile toxin test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Colostomy infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Iatrogenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Incision site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Metabolic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pancreatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Post procedural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Postoperative respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Small intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Suture related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Wound abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Wound Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'One Arm', 'description': 'Strattice Reconstructive Tissue Matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postoperatively up to 24 months', 'description': 'Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '80 patients were enrolled and received Strattice Reconstructive Tissue Matrix to support the repair and were included in the Intent to Treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Activities Assessment Scale (AAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Strattice Reconstructive Tissue Matrix', 'description': 'Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.\n\nLTM (Strattice Reconstructive Tissue Matrix): Surgical mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '21.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Activities Assessment Scale (AAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Strattice Reconstructive Tissue Matrix', 'description': 'Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.\n\nLTM (Strattice Reconstructive Tissue Matrix): Surgical mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '19.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Activities Assessment Scale (AAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Strattice Reconstructive Tissue Matrix', 'description': 'Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.\n\nLTM (Strattice Reconstructive Tissue Matrix): Surgical mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '78.2', 'spread': '16.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Activities Assessment Scale (AAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Strattice Reconstructive Tissue Matrix', 'description': 'Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.\n\nLTM (Strattice Reconstructive Tissue Matrix): Surgical mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'spread': '14.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Activities Assessment Scale (AAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Strattice Reconstructive Tissue Matrix', 'description': 'Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.\n\nLTM (Strattice Reconstructive Tissue Matrix): Surgical mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '83.5', 'spread': '17.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Activities Assessment Scale (AAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Strattice Reconstructive Tissue Matrix', 'description': 'Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.\n\nLTM (Strattice Reconstructive Tissue Matrix): Surgical mesh'}], 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'spread': '17.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Strattice Tissue Matrix'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '83 subjects enrolled, 80 subjects received Strattice reinforcement of hernia repair', 'groupId': 'FG000', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '67 subjects completed study; 7 completed early, 60 completed 24 month visit', 'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'insurance concerns', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '83 subjects enrolled between Sep 2007 and Aug 2008 from 12 US sites and followed for 24 months following hernia repair', 'preAssignmentDetails': '83 subjects were enrolled, 3 were not implanted, resulting in 80 subjects implanted with device (ITT group).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'One Arm', 'description': 'Strattice Reconstructive Tissue Matrix'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '83 subjects enrolled, of which 80 subjects were implanted. The ITT population is defined as subjects enrolled and implanted (n=80).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2008-01-14', 'resultsFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-29', 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Wound Events', 'timeFrame': 'Postoperatively up to 24 months', 'description': 'Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.'}], 'secondaryOutcomes': [{'measure': 'Activities Assessment Scale (AAS)', 'timeFrame': 'Baseline', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity.'}, {'measure': 'Activities Assessment Scale (AAS)', 'timeFrame': '30 Days', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.'}, {'measure': 'Activities Assessment Scale (AAS)', 'timeFrame': '3 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.'}, {'measure': 'Activities Assessment Scale (AAS)', 'timeFrame': '6 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.'}, {'measure': 'Activities Assessment Scale (AAS)', 'timeFrame': '12 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.'}, {'measure': 'Activities Assessment Scale (AAS)', 'timeFrame': '24 Months', 'description': 'The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['incisional hernia', 'abdominal hernia repair', 'Ventral incisional hernia repair'], 'conditions': ['Hernia']}, 'referencesModule': {'references': [{'pmid': '22763262', 'type': 'RESULT', 'citation': 'Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3.'}, {'pmid': '22415440', 'type': 'DERIVED', 'citation': 'Rosen MJ, Denoto G, Itani KM, Butler C, Vargo D, Smiell J, Rutan R. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia. 2013 Feb;17(1):31-5. doi: 10.1007/s10029-012-0909-2. Epub 2012 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* is an adult ≥18 years old.\n* has need of open abdominal incisional repair of a contaminated or infected site\n* has an estimated hernia size of \\>9cm2 by physical exam\n\nExclusion Criteria:\n\n* has a nidus of chronic colonization\n* has a systemic infection at the time of repair.\n* has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder.\n* requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.\n* is bedridden or otherwise non-ambulatory.\n* is ASA Class 4 or 5.\n* has a BMI \\>40.\n* has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.'}, 'identificationModule': {'nctId': 'NCT00617357', 'acronym': 'RICH', 'briefTitle': 'Repair of Infected or Contaminated Hernias', 'organization': {'class': 'INDUSTRY', 'fullName': 'LifeCell'}, 'officialTitle': 'A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM', 'orgStudyIdInfo': {'id': 'LFC2007.02.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Strattice Reconstructive Tissue Matrix', 'interventionNames': ['Device: LTM (Strattice Reconstructive Tissue Matrix)']}], 'interventions': [{'name': 'LTM (Strattice Reconstructive Tissue Matrix)', 'type': 'DEVICE', 'description': 'Surgical mesh', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California-San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hospital of St Rafael', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri-Columbia Medical Center', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital-Long Island Jewish Health System', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Kamal Itani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston VA Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LifeCell', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}