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

NeuroTherapia, Inc.

Status: Completed

Conditions: Endovascular Procedures

Treatments: Other: Prevena Dressing; Other: Conventional Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03105154

15-1402

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

Prevena Dressing

Experimental group

Description:

Groin dressed with Prevena

Treatment:

Other: Prevena Dressing

Conventional Dressing

Active Comparator group

Description:

Groin dressed with conventional bandage

Treatment:

Other: Conventional Dressing