Prophylactic Muscle Flaps in Vascular Surgery

University of Wisconsin (UW)

Status: Terminated

Conditions: Vascular Graft Infection

Treatments: Procedure: Prophylactic muscle flap

Study type: Interventional

Funder types: Other

Identifiers

NCT04399044

Protocol Version 3/11/2020 (Other Identifier)

A539730 (Other Identifier)

2019-1186

SMPH/SURGERY/DENTL-PLASTC SRGY (Other Identifier)

Details and patient eligibility

About

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 complications and re-operation. This is a prospective randomized control trial to test this hypothesis at the University of Wisconsin Hospitals and Clinics.

Full 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 estimated to be between 11 and 13%. Retrospective studies have endeavored to create risk calculators to better predict patients at high risk of need for muscle flap salvage. Fischer et al. suggest that in high-risk patients, prophylactic muscle flaps can reduce complications from 70% to 10%, rates of infection from 70% to 3% and wound breakdown from 48% to 5%. Cost-savings of around $400,000 per year with the use of prophylactic muscle flaps are estimated. Unfortunately, the retrospective nature of the Fischer et al. study, lack of standardization of patients receiving prophylactic muscle flaps, and use of the same cohort for the risk calculator as for the outcomes analysis all reduce the generalizability and reproducibility of these results.

At the University of Wisconsin Hospitals and Clinics, muscle coverage is routinely used in cases of infection or lymph leak but is not systematically used in prophylactic settings. This is because it is generally left to surgeon preference-if they feel like a muscle flap is needed (for a variety of non-standardized anatomic/surgical or patient factors) then it is performed. Muscle coverage of vascular grafts in and of itself is not an experimental procedure and has been performed for decades.

The goal of this study is to determine whether prophylactic muscle flaps in high-risk patients can a) reduce the rates of infection requiring re-operation, and b) reduce the significant morbidity associated with other non-operative complications. This will be the first prospective, randomized control trial to address this issue.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open lower extremity arterial revascularization
• Groin incision
• "High-risk" patients based on risk calculation

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Group 1: No flap

No Intervention group

Description:

Participants will undergo the scheduled vascular surgery procedure without involvement of the plastic surgery team and use of muscle flaps for graft coverage.

Group 2: Prophylactic muscle flap

Experimental group

Description:

Participants will undergo the scheduled vascular surgery procedure and then a muscle flap will be used to cover the vascular graft by a plastic surgeon in the same setting.

Treatment:

Procedure: Prophylactic muscle flap