CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Prevena negative pressure wound systemdevice
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/NCT01637870
NCT01637870N/ACompleted

Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications

Abbey Hardy-Fairbanks·interventional·Posted Jul 11, 2012·Updated Apr 18, 2018

In Brief

A clinical study evaluating Prevena negative pressure wound system for Major Puerperal Infection, Postpartum and 4 related conditions. Completed, enrolled 110 participants across 1 site.

Detailed Summary

This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups. It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2012
Enrollment StartAug 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.0 years ago

Interventions

Prevena negative pressure wound systemdevice

Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication