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
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
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Completed NA
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Sep 2024 — Present [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Mar 2021 — Jul 2024 [monthly]
Completed NA
Status: Recruiting → Completed
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Jan 2021 — Mar 2021 [monthly]
Recruiting NA
▶ Show 4 earlier versions
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Feb 2020 — Jan 2021 [monthly]
Recruiting NA
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Mar 2019 — Feb 2020 [monthly]
Recruiting NA
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Jun 2018 — Mar 2019 [monthly]
Recruiting NA
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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
- The Cleveland Clinic
For direct contact, visit the study record on ClinicalTrials.gov .