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

Endovascular Procedures Clinical Trial

— PREVENA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105154
• Other study ID #: 15-1402
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 10, 2020

Study information

• Verified date: February 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Procedures
• Wound Infection

Intervention

Other:
• Prevena Dressing
Prevena dressing is applied on one groin
• Conventional Dressing
Conventional dressing is applied on the contralateral groin

Locations

Country	Name	City	State
United States	Clevealnd Clnic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of infection at 30 days	% of wound occurrence in the Prevena treated groin compared to conventional treated groin	30 days