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

Primary Purpose

Endovascular Procedures

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prevena Dressing

Conventional Dressing

About this trial

This is an interventional treatment trial for Endovascular Procedures

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Clevealnd Clnic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prevena Dressing

Conventional Dressing

Arm Description

Groin dressed with Prevena

Groin dressed with conventional bandage

Outcomes

Primary Outcome Measures

% of infection at 30 days

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03105154

First Posted

March 14, 2017

Last Updated

February 10, 2021

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03105154

Brief Title

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

Acronym

PREVENA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

November 10, 2020 (Actual)

Study Completion Date

November 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endovascular Procedures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prevena Dressing

Arm Type

Experimental

Arm Description

Groin dressed with Prevena

Arm Title

Conventional Dressing

Arm Type

Active Comparator

Arm Description

Groin dressed with conventional bandage

Intervention Type

Other

Intervention Name(s)

Prevena Dressing

Intervention Description

Prevena dressing is applied on one groin

Intervention Type

Other

Intervention Name(s)

Conventional Dressing

Intervention Description

Conventional dressing is applied on the contralateral groin

Primary Outcome Measure Information:

Title

% of infection at 30 days

Description

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leveser Kirksey

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clevealnd Clnic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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