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Can operating within 72 hours save limbs after severe leg trauma?

NCT ID NCT07828613

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are comparing two timings for flap surgery in adults with severe open fractures or dislocations below the knee. One group receives a flap within 72 hours of injury, while the other follows the standard timing used at each hospital. The trial measures death, amputation, re-operation for infection or flap problems, and days spent in the hospital over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
accelerated flap coverage surgery, a reconstructive procedure that moves tissue to cover open wounds
What this could lead to
If accelerated flap timing works, hospitals could adopt a faster surgical schedule for severe open leg injuries, potentially lowering infection and amputation rates.
What could go wrong
The trial may find no difference between the two timings, or faster surgery may not be feasible at every hospital. Flap surgery itself carries risks of infection, bleeding, and flap failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 356 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients 18 years of age or older. * Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury. * Treating surgeon is willing to comply with treatment allocation. * Able to be randomized within 72 hours of injury. Exclusion Criteria: * Site is unable to implement the accelerated flap protocol due to local logistics. * Primary amputation anticipated prior to attempted flap for management of the injury. * Critical limb ischemia that requires re-vascularization for limb perfusion. * Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery. * Burns at the musculoskeletal injury site. * Incarceration. * Expected injury survival of less than 12 months. * Terminal illness with expected survival of less than 12 months. * Currently enrolled in a trial that does not permit co-enrollment. * Declined to provide informed consent. * Unable to obtain informed consent due to language barriers. * Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable. * Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. * Prior enrollment in the trial. * Eligible patient or LAR was not approached within screening window (missed participant). * Other reason to exclude the patient, as approved by the Principal Investigators.

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Open Leg Injuries tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extremity fracture lower Extremity injuries lower Open dislocation of ankle Open tibia fracture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Brown University Health

    Providence, Rhode Island, 02903, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90084, United States

  • IU Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Jamaica Hospital Medical Center

    The Bronx, New York, 11418, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Johns Hopkins Hospital - Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • Los Angeles Medical Center

    Los Angeles, California, 90033, United States

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Miami Valley Hospital

    Dayton, Ohio, 45409, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43221, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

  • UC San Diego Health

    San Diego, California, 92121, United States

  • UW Medical Center

    Seattle, Washington, 98195, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Maryland - Capital Region

    Largo, Maryland, 20774, United States

  • University of Maryland - Shock Trauma Center

    Baltimore, Maryland, 21201, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Missouri Hospital

    Columbia, Missouri, 65212, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

  • University of Wisconsin Health University Hospital

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

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