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Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836990
Recruitment Status : Completed
First Posted : July 19, 2016
Results First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
Linda Harris, State University of New York at Buffalo

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wound Infection Device: Prevena Incision Management System Device: Dermabond Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery
Study Start Date : July 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

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Arms and Interventions
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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 Name: Prevena
Active Comparator: Dermabond
Dermabond for vascular surgical groin wounds
 Device: Dermabond
A surgical skin adhesive used to prevent surgical wound infections


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Cost of Care [ Time Frame: 30 days ]
    Comparison of cost of treatment between the two arms

  2. 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.


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

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

Contacts and Locations
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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): NCT02836990


Locations
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United States, New York
Kaleida Health, Gates Vascular Institute
Buffalo, New York, United States, 14203
State University of New York at Buffalo
Buffalo, New York, United States, 14203
Sponsors and Collaborators
State University of New York at Buffalo
KCI USA, Inc.
Investigators
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Principal Investigator: Linda Harris, MD State University of New York at Buffalo
  Study Documents (Full-Text)

Documents provided by Linda Harris, State University of New York at Buffalo:
Informed Consent Form  [PDF] September 17, 2015
Study Protocol and Statistical Analysis Plan  [PDF] August 11, 2017

More Information
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Additional Information:

Publications:

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Responsible Party: Linda Harris, Professor, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02836990    
Other Study ID Numbers: Prevena
First Posted: July 19, 2016    Key Record Dates
Results First Posted: December 28, 2020
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Wounds and Injuries