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Groin incisions in vascular surgery have complications in up to 30% of cases at 30 days, resulting in reductions in patient quality of life and increased costs. Prior attempts at reducing this complication rate have been largely unsuccessful. The purpose of this study is to determine the feasibility of routine Vialize use for vascular surgeries involving a groin incision and to determine the rates of surgical site infection/dehiscence in such patients receiving subcutaneous Vialize.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vialize | Other | Vialize is a lyophilized dehydrated complete human placental membrane allograft. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vialize | Other | Any patients undergoing surgeries involving a groin incision (e.g., femoropopliteal bypass, aortofemoral bypass, loop thigh graft, femoral exposure for delivery of device) will receive Vialize subcutaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision. | Aim 1 | 90-day post-op follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The patient quality of life (EQ-5D) | 90-day post-op follow-up | |
| return to OR for groin infection | 90-day post-op follow-up | |
| Readmission or prolongation of the index admission for groin infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir Shah, MD, MPH | COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health Heart & Vascular Hospital | Gainesville | Florida | 32608 | United States |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Patients from 2 populations will be included: high-risk patients (any of the following: redo groin incision, active smoker, A1c >/= 9.0, BMI >/= 30) and non-high-risk patients.
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| 90-day post-op follow-up |