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

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032949
• Other study ID #: IRB202301216
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Tam Nguyen
• Phone: 352-273-5482
• Email: tam.nguyen[@]surgery.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	UF Health Heart & Vascular Hospital	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The patient quality of life (EQ-5D)		90-day post-op follow-up
Secondary	return to OR for groin infection		90-day post-op follow-up
Secondary	Readmission or prolongation of the index admission for groin infection		90-day post-op follow-up