Clinical trial NCT04399044: Prophylactic Muscle Flaps in Vascular Surgery
Official title: Prophylactic Muscle Flaps for the Prevention of Vascular Graft Infection After Groin Dissection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Graft Infection
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Graft Infection Requiring Re-operation
timeFrame: within 1 year
Secondary outcomes:
measure: Incidence of Infection Not Requiring Re-operation
timeFrame: 1 year
measure: Incidence of Seroma
timeFrame: 1 year
measure: Incidence of Lymphocele
timeFrame: 1 year
measure: Incidence of Wound Dehiscence
timeFrame: 1year
measure: Toronto Lower Extremity Salvage Score (TESS) at 3 months
timeFrame: 3 months
measure: Toronto Lower Extremity Salvage Score (TESS) at 6 months
timeFrame: 6 months
measure: Toronto Lower Extremity Salvage Score (TESS) at 9 months
timeFrame: 9 months
measure: Toronto Lower Extremity Salvage Score (TESS) at 12 months
timeFrame: 12 months
measure: Readmission rates
timeFrame: 30- and 90-days
measure: Total cost of hospitalizations for index diagnosis
timeFrame: 1 year
measure: Number of clinic visits after index surgery
timeFrame: 1 year
measure: Death
timeFrame: 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Katherine Gast, MD
role: STUDY_CHAIR
References:
citation: Fischer JP, Nelson JA, Rohrbach JI, Wu LC, Woo EY, Kovach SJ, Low DW, Serletti JM, Kanchwala S. Prophylactic muscle flaps in vascular surgery: the Penn Groin Assessment Scale. Plast Reconstr Surg. 2012 Jun;129(6):940e-949e. doi: 10.1097/PRS.0b013e31824ecb17.
citation: Fischer JP, Nelson JA, Shang EK, Wink JD, Wingate NA, Woo EY, Jackson BM, Kovach SJ, Kanchwala S. Predicting the need for muscle flap salvage after open groin vascular procedures: a clinical assessment tool. J Plast Surg Hand Surg. 2014 Dec;48(6):389-95. doi: 10.3109/2000656X.2014.899242. Epub 2014 Mar 25.
citation: Bennett KM, Levinson H, Scarborough JE, Shortell CK. Validated prediction model for severe groin wound infection after lower extremity revascularization procedures. J Vasc Surg. 2016 Feb;63(2):414-9. doi: 10.1016/j.jvs.2015.08.094. Epub 2015 Oct 30.