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

Not Applicable

Completed

• Conditions: Vascular Diseases
• Interventions: Other: Vialize

• Registration Number: NCT06032949
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-13
• Study Start: 2023-10-23
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vialize	Vialize	Vialize is a lyophilized dehydrated complete human placental membrane allograft.

Primary Outcome Measures

Name	Time	Method
The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.	90-day post-op follow-up	Aim 1

Secondary Outcome Measures

Name	Time	Method
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
The patient quality of life (EQ-5D)	90-day post-op follow-up

Trial Locations

Locations (1)

UF Health Heart & Vascular Hospital; 🇺🇸 Gainesville, Florida, United States