Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Wound Infection

Intervention / Treatment
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* Device: Prevena Incision Management System
* Device: Dermabond


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prevena<br>Prevena Incision Management System for vascular surgical groin wounds | Device: Prevena Incision Management System<br>* A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections<br>* Other names: Prevena;|
| Active Comparator: Dermabond<br>Dermabond for vascular surgical groin wounds | Device: Dermabond<br>* A surgical skin adhesive used to prevent surgical wound infections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond | 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 | 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 | Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed. | 30 days |