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The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions

Surgical Site Infection Clinical Trial

Official title:
A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery

Clinical Trial Summary

The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.

Clinical Trial Description

This is a randomized, open-label, single-center, Phase IV, comparative interventional study looking at the effect of the Prevena™ Incision Management System (PIMS) on Cesarean section Subjects compared to a control arm treated with a standard-of-care surgical incision dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PIMS on closed incisions. Clinical outcomes of interest for this study are defined as Surgical Site Occurrences (SSOs) that include unanticipated local inflammatory response, prolonged drainage, fluid collection, dehiscence, and surgical site infection (SSI). This investigation will compare these outcomes to a control group consisting of Subjects screened for the same inclusion and exclusion criteria but treated with a standard-of-care surgical incision dressing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01450631
Study type Interventional
Source 3M
Contact
Status Completed
Phase N/A
Start date February 2012
Completion date December 2013
View Details
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