Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-14 @ 7:52 AM
Study NCT ID:
NCT02395159
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound infections', 'timeFrame': '7 days after the surgery', 'description': 'The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.'}], 'secondaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': 'up to 10 days'}, {'measure': 'antibiotic therapy', 'timeFrame': 'up to 30 days'}, {'measure': 'revision surgery', 'timeFrame': 'up to 30 days'}, {'measure': 'necessity of alternative wound dressings', 'timeFrame': 'up to 30 days'}, {'measure': 'prolongation of ambulant treatment', 'timeFrame': 'up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vascular surgery patients', 'wound management'], 'conditions': ['Infections']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.', 'detailedDescription': 'Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.\n\nThe aim is to demonstrate that the application of the Prevena™ IMS significantly reduces the incidence of postoperative wound infections. The wound infections will be classified according to Szilagyi.\n\nThe treatment phase begins following vascular surgery with wound management using either the Prevena™ IMS or a standard wound dressing, depending on the group to which the patient was randomly assigned. It involves a minimum stay of 7 and maximum 10 days in hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vascular surgery via right or left inguinal approach\n* nicotine abuse (active or according to medical condition)\n* risk factors:\n\n 1. cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)\n 2. metabolic disorders (diabetes mellitus type I type II, lipopathy or hyperhomocysteinemia) or chronic or acute renal insufficiency\n* previous vascular surgery with inguinal approach\n* signed informed consent form\n* persons who are legally competent and mentally able to comprehend and follow the instructions of study personnel\n\nExclusion Criteria:\n\n* local skin infections (fungal infections, acne)\n* pregnant and breast-feeding women\n* simultaneous participation in another clinical trial\n* persons who have been committed to an institution by court or administrative order\n* persons in a dependency or employment relationship with the sponsor or investigator'}, 'identificationModule': {'nctId': 'NCT02395159', 'acronym': 'IMS', 'briefTitle': 'Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Reduction of Groin Wound Infections After Vascular Surgery in Patients With Risk Factors by the Use a Negative Pressure Wound Incision Management System (KCI Prevena)', 'orgStudyIdInfo': {'id': '14-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevena™ IMS', 'description': 'The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery', 'interventionNames': ['Device: Prevena™ IMS']}, {'type': 'OTHER', 'label': 'sterile plaster dressings', 'description': 'The wound will be treated with the conventional wound management method of sterile plaster dressing.', 'interventionNames': ['Other: sterile plaster dressings']}], 'interventions': [{'name': 'Prevena™ IMS', 'type': 'DEVICE', 'description': 'Prevena™ IMS is intended for the management of the surgical incision environment and surrounding healthy skin in patients with a risk of postoperative complications such as infections. This entails the maintenance of a closed environment around the incision by applying a negative pressure wound therapy system.\n\nThe corresponding dressing is known under the name Prevena™ Dressing. The layer closest to the skin comprises silver foil, which reduces the microbial colonisation of cells.', 'armGroupLabels': ['Prevena™ IMS']}, {'name': 'sterile plaster dressings', 'type': 'OTHER', 'description': 'standard wound management method of sterile plaster dressings', 'armGroupLabels': ['sterile plaster dressings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'University Hospital Aachen, vascular surgery', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '58452', 'city': 'Witten', 'country': 'Germany', 'facility': 'Marienhospital Wiiten, vascular surgery', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}], 'overallOfficials': [{'name': 'Jochen Grommes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Aachen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}