Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

Not Applicable

Completed

• Conditions: Wound Infection
• Interventions: Device: Prevena Incision Management System; Device: Dermabond

• Registration Number: NCT02836990
• Lead Sponsor: State University of New York at Buffalo

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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Results First Submitted: 2020-02-25
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Results First Posted: 2020-12-28
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevena	Prevena Incision Management System	Prevena Incision Management System for vascular surgical groin wounds
Dermabond	Dermabond	Dermabond for vascular surgical groin wounds

Primary Outcome Measures

Name	Time	Method
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond	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

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

Trial Locations

Locations (2)

Kaleida Health, Gates Vascular Institute; 🇺🇸 Buffalo, New York, United States

State University of New York at Buffalo; 🇺🇸 Buffalo, New York, United States