Back to resultsVialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
Primary Purpose
Vascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vialize
Sponsored by
About this trial
This is an interventional health services research trial for Vascular Diseases focused on measuring groin infections, quality of life, readmission, groin incisions
Eligibility Criteria
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.
Sites / Locations
- UF Health Heart & Vascular HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vialize
Arm Description
Vialize is a lyophilized dehydrated complete human placental membrane allograft.
Outcomes
Primary Outcome Measures
The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
Aim 1
Secondary Outcome Measures
The patient quality of life (EQ-5D)
return to OR for groin infection
Readmission or prolongation of the index admission for groin infection
Full Information
NCT ID
NCT06032949
First Posted
September 5, 2023
Last Updated
October 23, 2023
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT06032949
Brief Title
Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
Official Title
Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
Keywords
groin infections, quality of life, readmission, groin incisions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vialize
Arm Type
Other
Arm Description
Vialize is a lyophilized dehydrated complete human placental membrane allograft.
Intervention Type
Other
Intervention Name(s)
Vialize
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
Description
Aim 1
Time Frame
90-day post-op follow-up
Secondary Outcome Measure Information:
Title
The patient quality of life (EQ-5D)
Time Frame
90-day post-op follow-up
Title
return to OR for groin infection
Time Frame
90-day post-op follow-up
Title
Readmission or prolongation of the index admission for groin infection
Time Frame
90-day post-op follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tam Nguyen
Phone
352-273-5482
Email
tam.nguyen@surgery.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Hanson
Phone
352-273-5479
Email
nancy.hanson@surgery.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Shah, MD, MPH
Organizational Affiliation
COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Heart & Vascular Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-733-8159
12. IPD Sharing Statement
Learn more about this trial
Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
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