Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Battle of the bandages: antibiotic beads take on wound vacs for broken legs

NCT ID NCT05615844

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 7 times

Summary

This Phase 3 trial tests whether antibiotic cement beads or negative pressure wound therapy (a wound vac) works better for severe open tibia fractures. 312 adults with these injuries will be randomly assigned to one of the two treatments. Researchers will compare death, amputation, unplanned surgeries, and bone healing over 6 months.

What this could mean

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

Active substance
Antibiotic cement beads (vancomycin and tobramycin mixed with PMMA cement)
What this could lead to
If it works, this could show that antibiotic beads are better than standard wound vacs at preventing infections and helping bones heal after severe open leg fractures.
What could go wrong
This is a Phase 3 trial, but results may not apply to all fracture types or hospitals. Both treatments are already used, so the difference may be small. Risks include infection, amputation, or need for more surgery.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 312 people

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

Started

Nov 2023

Expected to finish

Oct 2027

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.

The inclusion criteria are: 1. Patients 18 years of age or older. 2. Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture. 3. Planned internal or external fixation for definitive fracture management. 4. Formal surgical debridement within 72 hours of their injury. 5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. Informed consent obtained. The exclusion criteria are: 1. Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization). 2. Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin. 3. Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure. 4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable). 5. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 6. Incarceration. 7. Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months. 8. Currently enrolled in a study that does not permit co-enrollment. 9. Unable to obtain informed consent due to language barriers. 10. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. 11. Prior enrollment in the trial. 12. Other reason to exclude the patient, as approved by the Methods Center.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Open tíbia fracture are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

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

Open tíbia 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 in 2 countries. 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

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Bon Secours Mercy Health

    RECRUITING

    Cincinnati, Ohio, 45237, United States

  • Bryan Medical Center

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Dignity Health Chandler Regional Medical Center

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Inova Fairfax

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6C 2R6, Canada

  • Ortegon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Prisma Health - Midlands

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Royal Columbian Hospital

    RECRUITING

    New Westminster, British Columbia, V3L 3W7, Canada

  • Sanford Health

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Medical Center

    RECRUITING

    Fargo, North Dakota, 58103, United States

  • Slocum Center

    RECRUITING

    Eugene, Oregon, 97401, United States

  • St. Luke's University Health Network

    WITHDRAWN

    Bethlehem, Pennsylvania, 18015, United States

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1Y 4E9, Canada

  • University Medical Center of Southern Nevada

    WITHDRAWN

    Las Vegas, Nevada, 89102, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85721, United States

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • University of California, Davis

    RECRUITING

    Davis, California, 95616, United States

  • University of California, Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32611, United States

  • University of Florida Health Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • University of Maryland Capital Region Health

    RECRUITING

    Largo, Maryland, 20774, United States

  • University of Maryland, R Adams Cowley Shock Trauma Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33146, United States

  • University of Mississippi

    RECRUITING

    University, Mississippi, 38677, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Wisconsin

    WITHDRAWN

    Madison, Wisconsin, 53792, United States

  • Yale University

    WITHDRAWN

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.