- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399044
Prophylactic Muscle Flaps in Vascular Surgery
Prophylactic Muscle Flaps for the Prevention of Vascular Graft Infection After Groin Dissection
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53704
- University of Wisconsin Hospital and Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Graft Infection Requiring Re-operation
Time Frame: within 1 year
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Infection of the vascular graft as determined by clinical diagnosis which requires re-operation for washout or other indicated procedures
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within 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 1 year
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1 year
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Incidence of Infection Not Requiring Re-operation
Time Frame: 1 year
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Superficial infections treated with antibiotics alone or local wound cares
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1 year
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Incidence of Seroma
Time Frame: 1 year
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Fluid collection over the vascular graft
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1 year
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Incidence of Lymphocele
Time Frame: 1 year
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Collection of lymph fluid over vascular graft/operative field
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1 year
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Incidence of Wound Dehiscence
Time Frame: 1year
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Incision breakdown that is managed with wound cares and does not require operative debridement
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1year
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Toronto Lower Extremity Salvage Score (TESS) at 3 months
Time Frame: 3 months
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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).
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3 months
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Toronto Lower Extremity Salvage Score (TESS) at 6 months
Time Frame: 6 months
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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).
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6 months
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Toronto Lower Extremity Salvage Score (TESS) at 9 months
Time Frame: 9 months
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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).
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9 months
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Toronto Lower Extremity Salvage Score (TESS) at 12 months
Time Frame: 12 months
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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).
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12 months
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Readmission rates
Time Frame: 30- and 90-days
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Rates of re-hospitalization after the index revascularization
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30- and 90-days
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Total cost of hospitalizations for index diagnosis
Time Frame: 1 year
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1 year
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Number of clinic visits after index surgery
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Katherine Gast, MD, University of Wisconsin, Madison
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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