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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03105154

Acronym

PREVENA

Enrollment

Registered

2017-04-07

Start date

2016-02-29

Completion date

2020-11-10

Last updated

2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovascular Procedures

Brief 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.

Interventions

OTHERPrevena Dressing

Prevena dressing is applied on one groin

OTHERConventional Dressing

Conventional dressing is applied on the contralateral groin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Patient will be randomized sequentially to Prevena alternating with standard of care dressing

Eligibility

Sex/Gender

ALL

Age

21 Years to 100 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026