CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 93 enrolled
Drug / intervention
Standard Wound Closure +1 moreprocedure
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/NCT02309944
NCT02309944N/ACompleted
CompareCT.gov

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial

Masonic Cancer Center, University of Minnesota·interventional·Posted Dec 5, 2014·Updated Jul 27, 2020

In Brief

A clinical study evaluating Standard Wound Closure and Prevena™ Incision Management System for Postoperative Complications and 2 related conditions. Completed, enrolled 93 participants across 1 site.

Detailed Summary

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Complications, Obesity, Gynecologic Neoplasms
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 5, 2014
Enrollment StartMay 1, 2015
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.6 years ago

Interventions

Standard Wound Closureprocedure

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

Prevena™ Incision Management Systemdevice

At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.