Prophylactic Muscle Flaps in Vascular Surgery

Vascular Graft Infection Clinical Trial

Official title:

Prophylactic Muscle Flaps for the Prevention of Vascular Graft Infection After Groin Dissection

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04399044
• Other study ID #: 2019-1186
• Secondary ID: A539730SMPH/SURG
• Status: Suspended
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 70
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Vascular Graft Infection

Intervention

Procedure:
• Prophylactic muscle flap
A "muscle flap" refers to taking an expendable muscle with its vascular supply and moving it to a new area. In this case, the investigators will take a muscle from the leg or abdomen that is redundant (other muscles perform the same function) and moving it to cover vascular grafts to provide healthy tissue to prevent infection.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Graft Infection Requiring Re-operation	Infection of the vascular graft as determined by clinical diagnosis which requires re-operation for washout or other indicated procedures	within 1 year
Secondary	Incidence of Infection Not Requiring Re-operation	Superficial infections treated with antibiotics alone or local wound cares	1 year
Secondary	Incidence of Seroma	Fluid collection over the vascular graft	1 year
Secondary	Incidence of Lymphocele	Collection of lymph fluid over vascular graft/operative field	1 year
Secondary	Incidence of Wound Dehiscence	Incision breakdown that is managed with wound cares and does not require operative debridement	1year
Secondary	Toronto Lower Extremity Salvage Score (TESS) at 3 months	This is a 32-item survey of activities commonly performed in daily life, each item scored on a 5 point likert scale where 1 is 'impossible to do' and 5 is 'not at all difficult'. The total possible range of scores is 32 to 160 where higher scores indicate less difficulty in performing tasks. Scores are often standardized to a 100-point scale to account for unanswered questions (referring to activities that they do not normally perform in everyday life).	3 months
Secondary	Toronto Lower Extremity Salvage Score (TESS) at 6 months	This is a 32-item survey of activities commonly performed in daily life, each item scored on a 5 point likert scale where 1 is 'impossible to do' and 5 is 'not at all difficult'. The total possible range of scores is 32 to 160 where higher scores indicate less difficulty in performing tasks. Scores are often standardized to a 100-point scale to account for unanswered questions (referring to activities that they do not normally perform in everyday life).	6 months
Secondary	Toronto Lower Extremity Salvage Score (TESS) at 9 months	This is a 32-item survey of activities commonly performed in daily life, each item scored on a 5 point likert scale where 1 is 'impossible to do' and 5 is 'not at all difficult'. The total possible range of scores is 32 to 160 where higher scores indicate less difficulty in performing tasks. Scores are often standardized to a 100-point scale to account for unanswered questions (referring to activities that they do not normally perform in everyday life).	9 months
Secondary	Toronto Lower Extremity Salvage Score (TESS) at 12 months	This is a 32-item survey of activities commonly performed in daily life, each item scored on a 5 point likert scale where 1 is 'impossible to do' and 5 is 'not at all difficult'. The total possible range of scores is 32 to 160 where higher scores indicate less difficulty in performing tasks. Scores are often standardized to a 100-point scale to account for unanswered questions (referring to activities that they do not normally perform in everyday life).	12 months
Secondary	Readmission rates	Rates of re-hospitalization after the index revascularization	30- and 90-days
Secondary	Total cost of hospitalizations for index diagnosis		1 year
Secondary	Number of clinic visits after index surgery		1 year
Secondary	Death		1 year