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New DNA test could slash infection failures after broken bone surgery

NCT ID NCT07458230

Disease control Sponsor: Johns Hopkins Bloomberg School of Public Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests whether a new DNA test called Next Generation Sequencing (NGS) can help doctors better treat infections that happen after bone fracture surgery. About 250 adults with deep infections after fracture repair will be randomly assigned to get treatment based on standard tests or standard tests plus NGS. The goal is to see if NGS reduces the need for additional surgeries and improves recovery.

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 250 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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 to 84 years

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: * Age 18-84 years * History of extremity fracture proximal to the metatarsals and carpal bones treated with any type of internal fixation. Note that both healed and unhealed fractures are eligible. * Deep infection requiring surgery after fracture fixation as determined by either of the following: FRI confirmatory criteria CDC criteria (without the timeframe). This includes the possibility of culture negative infection but determined to be infection by treatment team. * Plan for treatment includes antibiotic therapy prescribed by Infectious Disease provider(s), regardless of SOCHB culture or NGS results. Exclusion Criteria: * Spine fractures * High risk of amputation based on the initial managing physician opinion * Incarcerated/institutionalized * Patient is too sick to have surgery, i.e., medical co-morbidities which preclude treatment with a general anesthetic * Prior history of chronic infection at the surgical site * Pathological fractures from a neoplastic process * History of Paget's Disease * Unavailable for the planned 12 months of follow-up (e.g., planned follow-up at a location other than one of the study sites) * Extremity fracture occurred more than 2 years prior to the hospital admission for the presenting infection

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Conditions

The condition(s) this trial relates to.

Surgical Wound Infection

As listed by the trial registrant

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

Fracture fixation Next generation sequencing (NGS) Surgical site infection (SSI)

How to take part

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

  1. The places running it

    18 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

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • Inova Fairfax Medical Campus

    Fairfax, Virginia, 22042, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • McGovern Medical School at UTHealth Houston

    Houston, Texas, 77030, United States

  • Methodist Hospital

    Indianapolis, Indiana, 46202, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • UVA Health University Medical Center

    Charlottesville, Virginia, 22908, United States

  • UW Health University Hospital

    Madison, Wisconsin, 53792, United States

  • University of Alabama

    Tuscaloosa, Alabama, 35487, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California

    Los Angeles, California, 90007, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Warren Alpert Medical School of Brown University

    Providence, Rhode Island, 02903, United States

More trials for these conditions

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