Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

December 23, 2020 updated by: Linda Harris, State University of New York at Buffalo

Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery

This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

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
    • New York
      • Buffalo, New York, United States, 14203
        • State University of New York at Buffalo
      • Buffalo, New York, United States, 14203
        • Kaleida Health, Gates Vascular Institute

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:

  1. In need of elective vascular procedure requiring ≥8 cm groin incision.
  2. Able to provide consent
  3. Able to care for wound or have support person to complete wound care
  4. Willing to comply with follow-up

Exclusion Criteria:

None

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Prevena
Prevena Incision Management System for vascular surgical groin wounds
Device: Prevena Incision Management System
A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections
Other Names:
  • Prevena
ACTIVE_COMPARATOR: Dermabond
Dermabond for vascular surgical groin wounds
Device: Dermabond
A surgical skin adhesive used to prevent surgical wound infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
Time Frame: 30 days

The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision).

Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection.

Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of Care
Time Frame: 30 days
Comparison of cost of treatment between the two arms
30 days
Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection
Time Frame: 30 days
Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed.
30 days

Collaborators and Investigators

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

Sponsor

State University of New York at Buffalo

Collaborators

3M

Investigators

  • Principal Investigator: Linda Harris, MD, State University of New York at Buffalo

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

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

July 1, 2016

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (ESTIMATE)

July 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prevena

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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