Prevena Vascular Groin Wound Study

October 20, 2015 updated by: Thomas Jefferson University

Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications

The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.

Study Type

Interventional

Enrollment (Anticipated)

150

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

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:

  • All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study

Exclusion Criteria:

  • Emergency procedure
  • Unable to give informed consent

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Risk - Prevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Device: Prevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Other Names:
  • Closed Incision Negative Pressure Device
Active Comparator: High Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Device: Dry gauze dressing care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Active Comparator: Low Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Device: Dry gauze dressing care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Groin Wound Complication
Time Frame: 30 days
Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of stay
Time Frame: 30 days
30 days
Return to Operating Room
Time Frame: 30 days
30 days
Hospital Readmission
Time Frame: 30 days
Readmission for wound complication
30 days
Index Hospital Cost
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Paul DiMuzio, MD, Thomas Jefferson University

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.

General Publications

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

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7179

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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