Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)
NCT ID: NCT02395159
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
204 participants
INTERVENTIONAL
2015-07-31
2017-10-10
Brief Summary
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Detailed Description
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The 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.
The 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Prevena™ IMS
The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery
Prevena™ IMS
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.
The 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.
sterile plaster dressings
The wound will be treated with the conventional wound management method of sterile plaster dressing.
sterile plaster dressings
standard wound management method of sterile plaster dressings
Interventions
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Prevena™ IMS
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.
The 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.
sterile plaster dressings
standard wound management method of sterile plaster dressings
Eligibility Criteria
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Inclusion Criteria
* nicotine abuse (active or according to medical condition)
* risk factors:
1. cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)
2. metabolic disorders (diabetes mellitus type I type II, lipopathy or hyperhomocysteinemia) or chronic or acute renal insufficiency
* previous vascular surgery with inguinal approach
* signed informed consent form
* persons who are legally competent and mentally able to comprehend and follow the instructions of study personnel
Exclusion Criteria
* pregnant and breast-feeding women
* simultaneous participation in another clinical trial
* persons who have been committed to an institution by court or administrative order
* persons in a dependency or employment relationship with the sponsor or investigator
18 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Jochen Grommes
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Aachen
Locations
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University Hospital Aachen, vascular surgery
Aachen, , Germany
Marienhospital Wiiten, vascular surgery
Witten, , Germany
Countries
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References
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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:CD015022. doi: 10.1002/14651858.CD015022.pub2.
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.
Other Identifiers
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14-048
Identifier Type: -
Identifier Source: org_study_id