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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2025-02-28

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.

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Detailed Description

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Conditions

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Vascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Vialize

Vialize is a lyophilized dehydrated complete human placental membrane allograft.

Group Type OTHER

Vialize

Intervention Type 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.

Interventions

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Vialize

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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes