Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-05 @ 1:27 AM
Study NCT ID:
NCT02581904
Status:
UNKNOWN
Last Update Posted:
2015-10-21
First Post:
2015-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevena Vascular Groin Wound Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D013529', 'term': 'Surgical Wound Dehiscence'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2015-10-08', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Groin Wound Complication', 'timeFrame': '30 days', 'description': 'Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma'}], 'secondaryOutcomes': [{'measure': 'Hospital Length of stay', 'timeFrame': '30 days'}, {'measure': 'Return to Operating Room', 'timeFrame': '30 days'}, {'measure': 'Hospital Readmission', 'timeFrame': '30 days', 'description': 'Readmission for wound complication'}, {'measure': 'Index Hospital Cost', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wound Infection', 'Peripheral Arterial Disease', 'Aneurysm', 'Surgical Wound Dehiscence']}, 'referencesModule': {'references': [{'pmid': '41159585', 'type': 'DERIVED', 'citation': 'Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.'}, {'pmid': '40260835', 'type': 'DERIVED', 'citation': 'Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.'}, {'pmid': '30126781', 'type': 'DERIVED', 'citation': 'Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.', 'detailedDescription': 'The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study\n\nExclusion Criteria:\n\n* Emergency procedure\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT02581904', 'briefTitle': 'Prevena Vascular Groin Wound Study', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications', 'orgStudyIdInfo': {'id': '7179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Risk - Prevena Care', 'description': 'The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.', 'interventionNames': ['Device: Prevena Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Risk - Dry Gauze Dressing Care', 'description': 'Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily', 'interventionNames': ['Device: Dry gauze dressing care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Risk - Dry Gauze Dressing Care', 'description': 'Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily', 'interventionNames': ['Device: Dry gauze dressing care']}], 'interventions': [{'name': 'Prevena Care', 'type': 'DEVICE', 'otherNames': ['Closed Incision Negative Pressure Device'], 'description': 'The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.', 'armGroupLabels': ['High Risk - Prevena Care']}, {'name': 'Dry gauze dressing care', 'type': 'DEVICE', 'description': 'Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily', 'armGroupLabels': ['High Risk - Dry Gauze Dressing Care', 'Low Risk - Dry Gauze Dressing Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Paul DiMuzio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}