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

NCT06032949 | Completed

• 1 other identifier: IRB202301216
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Keywords

groin infections; quality of life; readmission; groin incisions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The patient quality of life (EQ-5D)

  90-day post-op follow-up

• 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

Study Arms (1)

Vialize

OTHER

Vialize is a lyophilized dehydrated complete human placental membrane allograft.

Other: Vialize

Interventions

Vialize 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.

Vialize

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Heart & Vascular Hospital

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Samir Shah, MD, MPH

  COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: October 23, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)