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

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.

Study Overview

• Status: Completed
• Conditions: Endovascular Procedures
• Intervention / Treatment: Other: Prevena Dressing; Other: Conventional Dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Clevealnd Clnic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prevena Dressing; Groin dressed with Prevena	Other: Prevena Dressing; Prevena dressing is applied on one groin
ACTIVE_COMPARATOR: Conventional Dressing; Groin dressed with conventional bandage	Other: Conventional Dressing; Conventional dressing is applied on the contralateral groin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Leveser Kirksey, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): November 10, 2020
• Study Completion (ACTUAL): November 10, 2020

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: 15-1402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No