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NCT Number: NCT02836990

Prevena™ vs Dermabond in Groin Wound Infections in 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.

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Key information

Conditions

Wound Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaleida Health, Gates Vascular Institute, Buffalo, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Prevena Incision Management System

Device

A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections

Other names: Prevena

Dermabond

Device

A surgical skin adhesive used to prevent surgical wound infections

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • KCI USA, Inc

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2016
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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