Vascular Diseases
Conditions
Keywords
groin infections, quality of life, readmission, groin incisions
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.
Interventions
OTHERVialize
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.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision. | 90-day post-op follow-up | Aim 1 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed