deltatrials
Completed NA INTERVENTIONAL 2-arm NCT03105154

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

Sponsor: The Cleveland Clinic

Updated 9 times since 2017 Last updated: Feb 10, 2021 Started: Feb 29, 2016 Primary completion: Nov 10, 2020 Completion: Nov 10, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Endovascular Procedures, this trial is completed. The trial is conducted by The Cleveland Clinic and has accumulated 9 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~May 2017 – ~Jun 2018 · 13 months · monthly snapshotRecruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotRecruiting~Mar 2019 – ~Feb 2020 · 11 months · monthly snapshotRecruiting~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotRecruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotRecruiting~Mar 2021 – ~Jul 2024 · 40 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Mar 2021 — Jul 2024 [monthly]

    Completed NA

    Status: RecruitingCompleted

  5. Jan 2021 — Mar 2021 [monthly]

    Recruiting NA

Show 4 earlier versions
  1. Feb 2020 — Jan 2021 [monthly]

    Recruiting NA

  2. Mar 2019 — Feb 2020 [monthly]

    Recruiting NA

  3. Jun 2018 — Mar 2019 [monthly]

    Recruiting NA

  4. May 2017 — Jun 2018 [monthly]

    Recruiting NA

    First recorded

Feb 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • The Cleveland Clinic
Data source: The Cleveland Clinic

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations