ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02954835
Previous Study | Return to List | Next Study

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
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Brief Summary:
The purpose of this study is to compare wound infection rates between negative pressure therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.

Condition or disease Intervention/treatment Phase
Wound Infection Device: Prevena Device: Traditional Dressing Phase 4

Detailed Description:
This is a prospective, investigator-initiated, post-market data collection study comparing wound infection rates among patients undergoing vascular surgery involving groin incisions. Patients will be randomized on the day of surgery to receive the traditional sterile dry dressing or Prevena. Patients with 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. The patients with Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit. The Primary Objective of this study is to see if using negative pressure therapy decreases the rate of infection. The Secondary Objectives will include multivariate analysis to understand which patients may have a compounded benefit from Prevena (e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage and will be used in this study for on-label purposes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Prevena
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.




Primary Outcome Measures :
  1. Infection rate [ Time Frame: 17 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing vascular surgery with a groin incision.

Exclusion Criteria:

  • Allergy to silver.

Information from the National Library of Medicine

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


Contacts
Contact: Thomas Bernik, MD thomas.bernik@ehmchealth.org
Contact: Courtney Woodhull, PA courtney.woodhull@ehmchealth.org

Locations
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Charelle Allen       charelle.allen@ehmchealth.org   
Contact: Patricia Mieses       patricia.mieses@ehmchealth.org   
Principal Investigator: Thomas Bernik, MD         
Sponsors and Collaborators
Englewood Hospital and Medical Center
Investigators
Principal Investigator: Thomas Bernik, MD Englewood Hospital and Medical Center

Additional Information:
Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT02954835     History of Changes
Other Study ID Numbers: E-16-679
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Infection