Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-11 @ 8:41 PM
Study NCT ID:
NCT02041494
Status:
TERMINATED
Last Update Posted:
2021-04-14
First Post:
2014-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hobart.harris@ucsf.edu', 'phone': '(415) 514-3891', 'title': 'Dr. Hobart W. Harris, Chief of General Surgery', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected throughout the duration of the study, an average of 26 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.\n\nStrattice', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 27, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.\n\nSoftMesh/Ventralight ST', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 19, 'seriousNumAtRisk': 83, 'deathsNumAffected': 2, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'superficial SSI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DVT/pumonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'deep space infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.\n\nStrattice'}, {'id': 'OG001', 'title': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.\n\nSoftMesh/Ventralight ST'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 24 months after surgery', 'description': 'Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure includes patients that recurred before 2 years and were not followed for 2 years, and some patients that recurred were followed for 2 years.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced Surgical Site Infections.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.\n\nStrattice'}, {'id': 'OG001', 'title': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.\n\nSoftMesh/Ventralight ST'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after surgery', 'description': 'Number of patients who experienced surgical site infections as determined by physical examination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Generic Measure of Health-related Quality of Life and Hernia-specific Measure of Quality of Life With a Focus on Abdominal Wall Function', 'timeFrame': '24 months after surgery', 'description': 'Quality of life will be measured using the SF-36 and the HerQLes surveys.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Surgical Site Occurrences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.\n\nStrattice'}, {'id': 'OG001', 'title': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene.\n\nVentralight'}], 'classes': [{'title': 'Hematoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Seroma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Wound necrosis and other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to two years from surgery', 'description': 'Number of surgical site occurrences by type.', 'unitOfMeasure': 'surgical site occurence', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with a surgical site occurrence were included in this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Other Surgical Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.\n\nStrattice'}, {'id': 'OG001', 'title': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.\n\nSoftMesh/Ventralight ST'}], 'classes': [{'title': 'Urinary tract infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deep Vein Thrombosis/pulmonary embolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after surgery', 'description': 'Number of other surgical complications including: urinary tract infections, pneumonia, and Deep Vein Thrombosis/pulmonary embolism.', 'unitOfMeasure': 'occurence', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with other surgical complications were included in this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Activity Level', 'timeFrame': '24 months after surgery', 'description': 'Activity level will be measured using the Activity Assessment Scale.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Cost', 'timeFrame': '24 months after surgery', 'description': 'Overall costs will be measured using a combination approach comparing actual costs, allowed vs. paid amounts, and Medicare payment rates using diagnosis related groups (DRG) and resource-based relative value scale (RBRVS) data.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.\n\nStrattice'}, {'id': 'FG001', 'title': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.\n\nSoftMesh/Ventralight ST'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': "Adults (≥21 years of age) with a ventral hernia scheduled for an elective repair were eligible for inclusion. Recruitment and all surgical procedures were carried out from March 2014 through October 2018 at UCSF Medical Center). All participants were recruited via referral to the medical center's surgery clinics. Patients were only enrolled once."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.\n\nSoftMesh/Ventralight ST'}, {'id': 'BG001', 'title': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.\n\nStrattice'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], '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': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-23', 'size': 117313, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-21T15:46', 'hasProtocol': False}, {'date': '2014-07-23', 'size': 206968, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-21T15:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'whyStopped': 'Rising costs have made continuing the study untenable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2014-01-18', 'resultsFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2014-01-18', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-18', 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Generic Measure of Health-related Quality of Life and Hernia-specific Measure of Quality of Life With a Focus on Abdominal Wall Function', 'timeFrame': '24 months after surgery', 'description': 'Quality of life will be measured using the SF-36 and the HerQLes surveys.'}, {'measure': 'Number of Surgical Site Occurrences', 'timeFrame': 'Up to two years from surgery', 'description': 'Number of surgical site occurrences by type.'}, {'measure': 'Number of Other Surgical Complications', 'timeFrame': '30 days after surgery', 'description': 'Number of other surgical complications including: urinary tract infections, pneumonia, and Deep Vein Thrombosis/pulmonary embolism.'}, {'measure': 'Activity Level', 'timeFrame': '24 months after surgery', 'description': 'Activity level will be measured using the Activity Assessment Scale.'}, {'measure': 'Overall Cost', 'timeFrame': '24 months after surgery', 'description': 'Overall costs will be measured using a combination approach comparing actual costs, allowed vs. paid amounts, and Medicare payment rates using diagnosis related groups (DRG) and resource-based relative value scale (RBRVS) data.'}], 'primaryOutcomes': [{'measure': 'Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.', 'timeFrame': 'up to 24 months after surgery', 'description': 'Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Experienced Surgical Site Infections.', 'timeFrame': '30 days after surgery', 'description': 'Number of patients who experienced surgical site infections as determined by physical examination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hernia', 'Ventral', 'Incisional', 'Abdominal', 'Herniorrhaphy', 'Recurrence', 'Infection', 'Mesh', 'Biologic', 'Synthetic'], 'conditions': ['Hernia, Ventral']}, 'referencesModule': {'references': [{'pmid': '33443907', 'type': 'RESULT', 'citation': 'Harris HW, Primus F, Young C, Carter JT, Lin M, Mukhtar RA, Yeh B, Allen IE, Freise C, Kim E, Sbitany H, Young DM, Hansen S. Preventing Recurrence in Clean and Contaminated Hernias Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized Clinical Trial. Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336.'}]}, 'descriptionModule': {'briefSummary': 'Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. The purpose of this study is to compare the effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin (called a "biologic prosthetic"), and one that is made in a laboratory (called a "synthetic prosthetic"). This study will include some patients who have an infection in/near the hernia, and other patients who do not have an infection. We expect the synthetic mesh to be associated with a higher rate of early post-operative surgical site infection and fluid collections (seromas), while we expect the biologic mesh to be associated with a higher rate of recurrence.', 'detailedDescription': 'This is a prospective, single-blind, randomized study comparing the clinical efficacy and overall costs of two prosthetic meshes in the repair of complex ventral hernias. The two prosthetic meshes to be studied are Ventralight (Bard, Murray Hill, NJ), a synthetic mesh chiefly made of polypropylene and Strattice (LifeCell, Branchburg, NJ), a biologic mesh derived from porcine dermis. The study population will consist of patients who are in need of a repair of a complex ventral hernia. Patients will be enrolled in the study for 24 months following their operation or until they experience a recurrence of their hernia, whichever occurs first. The primary outcome variable is recurrence and the secondary outcome variables are post-operative surgical site infections and overall costs.\n\nThere is no universally agreed upon definition of what constitutes a "complex" ventral hernia. For our purposes, a "complex" ventral hernia is one that involves a compromised surgical field, in which gastrointestinal, biliary, or genitourinary procedures are performed, one in which the wound class is considered clean-contaminated, contaminated, or dirty due to other causes, such as infected meshes and enterocutaneous fistulas, or surgical procedures conducted in patients with large ventral hernia defects (\\>10 cm in any single dimension).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical evidence of a midline, ventral hernia, regardless of degree of wound contamination, with the exception of class IV wounds due to the presence/discovery of fecal peritonitis. Specifically, the repair will or will not involve a compromised surgical field in which gastrointestinal, biliary and/or genitourinary procedures will be performed. The surgical wound class may be classified as clean, or it may be classified as clean-contaminated, contaminated, or dirty-infected, due to the repair of an enterocutaneous fistula, takedown of an intestinal stoma and/or removal of infected mesh\n* Age \\>21\n* Negative pregnancy test\n* No allergic, religious or ethical objections to either polypropylene or porcine prosthetics\n* Signed, witnessed informed consent to take part in the study\n\nExclusion Criteria:\n\n* Lactating women\n* Patients who are unable to commit to the follow evaluations over 24 months\n* Severe malnutrition (serum albumin \\<2.0 in the setting of a normal CRP)\n* Use of an investigational agent within 1 month prior to study enrollment and/or planned during this study\n* Presence of pre-existing parenchymal liver disease characterized by the presence of Child's Class C liver dysfunction (including all of the following: bilirubin ≥ 3.0 mg/dL; albumin ≤ 3.0 mg/dL; refractory ascites; encephalopathy or coma; and poor nutritional status)\n* Immunocompromised patients, as evidenced by: administration of high doses of corticosteroids (i.e. doses ≥ 1.5 mg/kg/day of prednisone or equivalent) within 72 hours before study enrollment; status post solid organ transplant or bone marrow transplant and experiencing acute organ rejection or bone marrow failure or rejection; evidence of neutropenia (absolute neutrophil count ≤ 500 cells/mm3 (≤ 500 x 106 cells/L); chemotherapy or radiation therapy within 90 days before study enrollment; known AIDS; any disease sufficiently advanced to suppress resistance to infection (including, but not limited to leukemia, lymphoma or hypogammaglobulinemia); administration of immunoglobulin of G-CSF within 90 days before study enrollment\n* Ascites refractory to medical management\n* Presence of an underlying disease/injury with life expectancy less than two years and/or severe underlying disease that would preclude study entry (e.g. known malignancy)\n* Wound Classification IV due to the presence/discovery of fecal peritonitis. Other cases of wound class IV including presence of purulent inflammation, soft tissue/mesh infection, or visceral perforation resulting in a contained fistula (e.g. enterocutaneous fistula) are still considered eligible for enrollment."}, 'identificationModule': {'nctId': 'NCT02041494', 'acronym': 'CVHR', 'briefTitle': 'Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-stage Repair of Ventral Hernias in Clean and Contaminated Wounds.', 'orgStudyIdInfo': {'id': 'UCSF-NIDDK-1R21DK093006-01A1'}, 'secondaryIdInfos': [{'id': '1R21DK093006-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21DK093006-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synthetic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene.', 'interventionNames': ['Device: Ventralight']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biologic', 'description': 'Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.', 'interventionNames': ['Device: Strattice']}], 'interventions': [{'name': 'Ventralight', 'type': 'DEVICE', 'otherNames': ['Ventralight ST Mesh', 'K101851'], 'armGroupLabels': ['Synthetic']}, {'name': 'Strattice', 'type': 'DEVICE', 'otherNames': ['LTM Surgical Mesh', 'K070560'], 'armGroupLabels': ['Biologic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94131', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Hobart W. Harris, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hobart Harris', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief of General Surgery', 'investigatorFullName': 'Hobart Harris', 'investigatorAffiliation': 'University of California, San Francisco'}}}}