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Prophylactic Muscle Flaps in Vascular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399044
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Vascular Graft Infection Procedure: Prophylactic muscle flap Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Muscle Flaps for the Prevention of Vascular Graft Infection After Groin Dissection
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
No Intervention: Group 1: No flap
Participants will undergo the scheduled vascular surgery procedure without involvement of the plastic surgery team and use of muscle flaps for graft coverage.
Experimental: Group 2: Prophylactic muscle flap
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.
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.




Primary Outcome Measures :
  1. Incidence of Graft Infection Requiring Re-operation [ Time Frame: within 1 year ]
    Infection of the vascular graft as determined by clinical diagnosis which requires re-operation for washout or other indicated procedures


Secondary Outcome Measures :
  1. Incidence of Infection Not Requiring Re-operation [ Time Frame: 1 year ]
    Superficial infections treated with antibiotics alone or local wound cares

  2. Incidence of Seroma [ Time Frame: 1 year ]
    Fluid collection over the vascular graft

  3. Incidence of Lymphocele [ Time Frame: 1 year ]
    Collection of lymph fluid over vascular graft/operative field

  4. Incidence of Wound Dehiscence [ Time Frame: 1year ]
    Incision breakdown that is managed with wound cares and does not require operative debridement

  5. Toronto Lower Extremity Salvage Score (TESS) at 3 months [ Time Frame: 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).

  6. Toronto Lower Extremity Salvage Score (TESS) at 6 months [ Time Frame: 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).

  7. Toronto Lower Extremity Salvage Score (TESS) at 9 months [ Time Frame: 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).

  8. Toronto Lower Extremity Salvage Score (TESS) at 12 months [ Time Frame: 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).

  9. Readmission rates [ Time Frame: 30- and 90-days ]
    Rates of re-hospitalization after the index revascularization

  10. Total cost of hospitalizations for index diagnosis [ Time Frame: 1 year ]
  11. Number of clinic visits after index surgery [ Time Frame: 1 year ]
  12. Death [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399044


Contacts
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Contact: Katherine Gast, MD 608-265-9254 gast@surgery.wisc.edu
Contact: Shady Elmaraghi, MD 608-263-6400 selmaraghi@uwhealth.org

Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53704
Contact: Katherine Gast, MD    608-265-9254    gast@surgery.wisc.edu   
Contact: Shady Elmaraghi, MD    6082636400    selmaraghi@uwhealth.org   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Study Chair: Katherine Gast, MD University of Wisconsin, Madison
Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04399044    
Other Study ID Numbers: 2019-1186
A539730 ( Other Identifier: UW Madison )
SMPH/SURGERY/DENTL-PLASTC SRGY ( Other Identifier: UW Madison )
Protocol Version 3/11/2020 ( Other Identifier: UW Madison )
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection