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OpenTrials
Completed

NCT Number: NCT03105154

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

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

Completed

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clevealnd Clnic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevena Dressing

Other

Prevena dressing is applied on one groin

Conventional Dressing

Other

Conventional dressing is applied on the contralateral groin

Primary outcomes

  1. % of infection at 30 days

    Time frame: 30 days

    % of wound occurrence in the Prevena treated groin compared to conventional treated groin

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: PREVENA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2017
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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