CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 140 enrolled
Drug / intervention
Prevena Care +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/NCT02581904
NCT02581904Phase 4Completed
CompareCT.gov

Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications

Thomas Jefferson University·interventional·Posted Oct 21, 2015·Updated Feb 25, 2026

In Brief

A Phase 4 clinical trial evaluating Prevena Care and Dry gauze dressing care for Wound Infection and 3 related conditions. Completed, enrolled 140 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Infection, Peripheral Arterial Disease, Aneurysm, Surgical Wound Dehiscence
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 21, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2016
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.7 years ago

Interventions

Prevena Caredevice

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.

Dry gauze dressing caredevice

Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily