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Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevena Dressing | Experimental | Groin dressed with Prevena |
|
| Conventional Dressing | Active Comparator | Groin dressed with conventional bandage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Dressing | Other | Prevena dressing is applied on one groin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| % of infection at 30 days | % of wound occurrence in the Prevena treated groin compared to conventional treated groin | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leveser Kirksey | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clevealnd Clnic | Cleveland | Ohio | 44195 | United States |
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Patient will be randomized sequentially to Prevena alternating with standard of care dressing
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| Conventional Dressing |
| Other |
Conventional dressing is applied on the contralateral groin |
|