NCT03105154

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

4.8 years

First QC Date

March 14, 2017

Last Update Submit

February 10, 2021

Conditions

Endovascular Procedures

Outcome Measures

Primary Outcomes (1)

  • % of infection at 30 days

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

    30 days

Study Arms (2)

Prevena Dressing

EXPERIMENTAL

Groin dressed with Prevena

Other: Prevena Dressing

Conventional Dressing

ACTIVE COMPARATOR

Groin dressed with conventional bandage

Other: Conventional Dressing

Interventions

Prevena DressingOTHER

Prevena dressing is applied on one groin

Prevena Dressing
Conventional DressingOTHER

Conventional dressing is applied on the contralateral groin

Conventional Dressing

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate
  • pregnancy
  • unilateral femoral endarterectomy
  • subjects for whom Prevena IMS is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clevealnd Clnic

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Leveser Kirksey

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patient will be randomized sequentially to Prevena alternating with standard of care dressing
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 7, 2017

Study Start

February 1, 2016

Primary Completion

November 10, 2020

Study Completion

November 10, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)