Status:
TERMINATED
Prophylactic Muscle Flaps in Vascular Surgery
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Vascular Graft Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Previous studies have suggested that prophylactic muscle coverage in high-risk patients undergoing revascularization procedures through a groin incision have the potential to reduce rates of complicat...
Detailed Description
The incidence of graft infections after groin dissection for lower limb revascularization is estimated to be between 2 and 20%. Infection requiring re-operation and muscle flap coverage for salvage is...
Eligibility Criteria
Inclusion
- Open lower extremity arterial revascularization
- Groin incision
- "High-risk" patients based on risk calculation
Exclusion
- Pregnant or breast-feeding
- Any person with diagnosis of an active groin infection preoperatively
- Incarcerated patients
- Unstable patients going directly to the OR for whom the study consent process would delay care, and those who cannot give informed consent to participate in the research study will be excluded
- If a surgeon feels that a patient should or should not receive a flap based on intra-operative or pre-operative characteristics, those patients will be excluded from the study
- Prior to a scheduled groin intervention case a prior authorization will be sent to the participant's insurance company. If the groin flap is denied, which would be highly unusual, then the participant would be excluded from the study.
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04399044
Start Date
October 16 2020
End Date
February 26 2021
Last Update
June 27 2024
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53704