Status:
COMPLETED
Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
Lead Sponsor:
University of Florida
Conditions:
Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 complic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06032949
Start Date
October 23 2023
End Date
February 28 2025
Last Update
April 8 2025
Active Locations (1)
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1
UF Health Heart & Vascular Hospital
Gainesville, Florida, United States, 32608