NCT03105154

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

Experience With the Negative Pressure Incision Management System (Prevena) in Vascular Surgery Patients With High Risk for Groin Wound Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endovascular Procedures

Interventions

Type	Name	Description
OTHER	Prevena Dressing	Prevena dressing is applied on one groin
OTHER	Conventional Dressing	Conventional dressing is applied on the contralateral groin

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-11-10
• Completion: 2020-11-10
• First posted: 2017-04-07
• Last updated: 2021-02-11

Locations

1 site across 1 country: United States