CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 441 enrolled
Drug / intervention
Negative pressure wound therapydevice
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/NCT02289157
NCT02289157N/ACompleted
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Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean

University of Texas Southwestern Medical Center·interventional·Posted Nov 13, 2014·Updated Jul 2, 2018

In Brief

A clinical study evaluating Negative pressure wound therapy for Postoperative Wound Complications. Completed, enrolled 441 participants across 1 site.

Detailed Summary

The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Wound Complications
CountriesUnited States
CollaboratorsKCI USA, Inc

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 13, 2014
Enrollment StartJan 27, 2015
Primary CompletionAug 30, 2016
Study CompletionOct 21, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.6 years ago

Interventions

Negative pressure wound therapydevice

Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.