Negative Pressure Therapy for Groin Wounds
|ClinicalTrials.gov Identifier: NCT02954835|
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Wound Infection||Device: Prevena Device: Traditional Dressing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||September 3, 2019|
|Actual Study Completion Date :||September 3, 2019|
Active Comparator: Prevena
Subjects randomized to the Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit.
Prevena is a sterile silver dressing. On top of the silver dressing is an adhesive plastic, which is connected to a therapy unit through a short length suction tube.
Active Comparator: Traditional Dressing
Subjects randomized to the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon.
Device: Traditional Dressing
Sterile gauze dressing secured by tape.
- Infection rate [ Time Frame: 17 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954835
|United States, New Jersey|
|Englewood Hospital and Medical Center|
|Englewood, New Jersey, United States, 07631|
|Principal Investigator:||Thomas Bernik, MD||Englewood Hospital and Medical Center|