Groin Wound Infection Rate Using Prevena Compared to Standard Dressing in Vascular Surgery Patients With High Risk

Not Applicable

Completed

• Conditions: Endovascular Procedures
• Interventions: Other: Conventional Dressing; Other: Prevena Dressing

• Registration Number: NCT03105154
• Lead Sponsor: The Cleveland Clinic

Brief Summary

Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.

Detailed Description

Patients submitted to bilateral femoral endarterectomy will have one groin dressed with PrevenaTM and the contralateral one dressed with conventional bandage immediately after suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed before the patient discharge. Groin wound complications such as deep space infection, cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be observed in a 30-day evaluation window. This observation will be performed during the patient admission and in the post-operative standard of care visits among the first 30 days.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-07
• Primary Completion: 2020-11-10
• Study Completion: 2020-11-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Patients with known bilateral vascular peripheral disease who are being evaluated for possible bilateral femoral endarterectomy
• Patients with one or more risk factor (diabetes mellitus, Obesity, heavy smoker, immunodeficiency disease, groin reoperation, prosthetic)
• Patients in follow-up at Clinic in the Vascular Surgery Department
• Sign of informed consent
• English speaking

Exclusion Criteria

• Refusal to participate
• pregnancy
• unilateral femoral endarterectomy
• subjects for whom Prevena IMS is contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Dressing	Conventional Dressing	Groin dressed with conventional bandage
Prevena Dressing	Prevena Dressing	Groin dressed with Prevena

Primary Outcome Measures

Name	Time	Method
% of infection at 30 days	30 days	% of wound occurrence in the Prevena treated groin compared to conventional treated groin

Trial Locations

Locations (1)

Clevealnd Clnic; 🇺🇸 Cleveland, Ohio, United States