Negative Pressure Therapy for Groin Wounds
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02954835|
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Wound Infection||Device: Prevena Device: Traditional Dressing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 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|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954835
|Contact: Thomas Bernik, MDfirstname.lastname@example.org|
|Contact: Courtney Woodhull, PAemail@example.com|
|United States, New Jersey|
|Englewood Hospital and Medical Center||Recruiting|
|Englewood, New Jersey, United States, 07631|
|Contact: Charelle Allen firstname.lastname@example.org|
|Contact: Patricia Mieses email@example.com|
|Principal Investigator: Thomas Bernik, MD|
|Principal Investigator:||Thomas Bernik, MD||Englewood Hospital and Medical Center|