- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954835
Negative Pressure Therapy for Groin Wounds
February 5, 2020 updated by: Englewood Hospital and Medical Center
Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
2
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
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Englewood, New Jersey, United States, 07631
- Englewood Hospital and Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing vascular surgery with a groin incision.
Exclusion Criteria:
- Allergy to silver.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
Sterile gauze dressing secured by tape.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infection rate
Time Frame: 17 weeks
|
17 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Bernik, MD, Englewood Hospital and Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Actual)
September 3, 2019
Study Completion (Actual)
September 3, 2019
Study Registration Dates
First Submitted
November 2, 2016
First Submitted That Met QC Criteria
November 2, 2016
First Posted (Estimate)
November 3, 2016
Study Record Updates
Last Update Posted (Actual)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-16-679
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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