NCT06032949

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Diseases

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-10-23
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2023-09-13
• Last updated: 2025-04-08

Locations

1 site across 1 country: United States