Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection

Study Overview
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Brief Summary
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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.

Official Title
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Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection

Conditions
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Vascular Diseases

Intervention / Treatment
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* Other: Vialize


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study population will consist of patients undergoing vascular procedures with groin incisions. Patients must be at least 18- years-old and able to complete baseline measurements. All subjects will be compensated. Patients undergoing treatment for peripheral arterial disease (e.g., femoropopliteal bypass), aneurysm disease (e.g., aortofemoral bypass), end-stage kidney disease (e.g., loop thigh graft), and miscellaneous procedures (e.g., femoral exposure for delivery of device) will be eligible. Exclusion Criteria: Patients undergoing use of negative pressure wound therapy (e.g., Prevena) and local antibiotic placement (e.g., vancomycin powder) will be excluded. Additionally, organ-transplant recipients will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vialize<br>Vialize is a lyophilized dehydrated complete human placental membrane allograft. | Other: Vialize<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 90-day post-op follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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groin infections, quality of life, readmission, groin incisions