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Vascular Graft InfectionNCT04399044

Prophylactic Muscle Flaps in Vascular Surgery

A study testing Prophylactic muscle flap in people with Vascular Graft Infection, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vascular Graft Infection
What is being tested?
Prophylactic muscle flap
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
16 Oct 2020to 26 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53704

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Prophylactic muscle flap

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prophylactic muscle flapProcedure or surgery

    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.

Study groups in NCT04399044
Study groupRoleWhat they receive
Group 1: No flapNo interventionParticipants 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 flapExperimentalParticipants 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.
Receives: Procedure: Prophylactic muscle flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: within 1 year

Secondary outcomes (12)

  1. Incidence of Infection Not Requiring Re-operation

    Superficial infections treated with antibiotics alone or local wound cares

    Measured: 1 year

  2. Incidence of Seroma

    Fluid collection over the vascular graft

    Measured: 1 year

  3. Incidence of Lymphocele

    Collection of lymph fluid over vascular graft/operative field

    Measured: 1 year

  4. Incidence of Wound Dehiscence

    Incision breakdown that is managed with wound cares and does not require operative debridement

    Measured: 1year

  5. 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).

    Measured: 3 months

  6. 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).

    Measured: 6 months

  7. 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).

    Measured: 9 months

  8. 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).

    Measured: 12 months

  9. Readmission rates

    Rates of re-hospitalization after the index revascularization

    Measured: 30- and 90-days

  10. Total cost of hospitalizations for index diagnosis

    Measured: 1 year

  11. Number of clinic visits after index surgery

    Measured: 1 year

  12. Death

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start16 Oct 2020
  3. Primary completion26 Feb 2021
  4. Study completion26 Feb 2021

Why it stopped: per the Institutional Review Board

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399044
Sponsor's protocol ID
2019-1186
Other IDs
A539730, SMPH/SURGERY/DENTL-PLASTC SRGY, Protocol Version 3/11/2020
Status last verified
Jun 2024
First submitted
18 May 2020
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22327893

  • 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.

    PubMed 24666001

  • 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.

    PubMed 26526055

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic muscle flap in people with Vascular Graft Infection, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: per the Institutional Review Board). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Graft Infection Requiring Re-operation (time frame: within 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04399044, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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