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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:21 - 100
Updated:2/23/2019
Start Date:February 2016
End Date:December 2019
Contact:Leveser Kirksey, MD
Email:kirksel@ccf.org
Phone:216-444-2892

Use our guide to learn which trials are right for you!

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

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

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.

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
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44195
Phone: 216-444-2200
?
mi
from
Cleveland, OH
Click here to add this to my saved trials