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 |
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.
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.
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
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