CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 583 enrolled
Drug / intervention
dry gauze +1 moreother
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/NCT02682316
NCT02682316Phase 3Completed
CompareCT.gov

A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management

Memorial Sloan Kettering Cancer Center·interventional·Posted Feb 15, 2016·Updated Mar 18, 2025

In Brief

A Phase 3 clinical trial evaluating dry gauze and The Prevena Incision Management System for Negative-Pressure Wound Therapy. Completed, enrolled 583 participants across 10 sites.

Detailed Summary

The purpose of this study is to compare any good and bad effects of using the Prevena Incision Management System to using the usual standard dry gauze approach. The Prevena Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a portable vacuum device made of a sponge-like foam that is applied over your incision to help draw fluid and debris out after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNegative-Pressure Wound Therapy
CountriesUnited States
Collaborators3M, Miami Cancer Institute

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 15, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJan 25, 2024
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 10.4 years ago

Interventions

dry gauzeother

The Prevena Incision Management Systemdevice