CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 272 enrolled
Drug / intervention
PREVENA™ PEEL & PLACE™ Dressing Kitdevice
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/NCT03773575
NCT03773575N/ACompleted
CompareCT.gov

Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

Thomas Jefferson University·interventional·Posted Dec 12, 2018·Updated Mar 25, 2026

In Brief

A clinical study evaluating PREVENA™ PEEL & PLACE™ Dressing Kit for Amputation and 5 related conditions. Completed, enrolled 272 participants across 3 sites in 2 countries.

Detailed Summary

This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation, Amputation; Postoperative, Sequelae, Wound Dehiscence, Seroma, Wound Infection, Surgical, Lymph Leakage
CountriesItaly, United States
CollaboratorsAcelity

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 12, 2018
Enrollment StartJan 15, 2019
Primary CompletionJul 15, 2024
Study CompletionAug 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 7.6 years ago

Interventions

PREVENA™ PEEL & PLACE™ Dressing Kitdevice

In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).