CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 204 enrolled
Drug / intervention
Prevena™ IMS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02395159
NCT02395159N/ACompleted
CompareCT.gov

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)

RWTH Aachen University·interventional·Posted Mar 20, 2015·Updated Oct 27, 2017

In Brief

A clinical study evaluating Prevena™ IMS and sterile plaster dressings for Infections. Completed, enrolled 204 participants across 2 sites.

Detailed Summary

Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartJul 1, 2015
Primary CompletionJul 1, 2017
Study CompletionOct 10, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.3 years ago

Interventions

Prevena™ IMSdevice

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 dressingsother

standard wound management method of sterile plaster dressings