TerminatedNot Applicable

Prophylactic Muscle Flaps in Vascular Surgery

Stopped: per the Institutional Review Board

United States5 participantsStarted 2020-10-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Graft Infection Requiring Re-operation

Timeframe: within 1 year

Trial details

NCT IDNCT04399044

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-26

View on ClinicalTrials.gov More Vascular Graft Infection trials