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Can a simple antibiotic shot stop open fracture infections?

NCT ID NCT04964947

Disease control Sponsor: Massachusetts General Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding a local injection of the antibiotic tobramycin to standard IV antibiotics can lower infection rates after open fracture surgery. Open fractures have a high risk of infection because the wound may not get enough blood flow for IV antibiotics to work well. The study enrolls 600 adults with open fractures of the arm or leg and will track infections for one year.

What this could mean

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

Active substance
tobramycin injection
What this could lead to
If it works, this could provide a simple, low-cost way to prevent serious infections after open fractures, reducing the need for repeat surgeries.
What could go wrong
This is a single trial with 600 participants, so results may not apply to everyone. Tobramycin can cause allergic reactions or kidney issues, and the added benefit over standard care may be small.

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

600 people

The number who actually took part.

Started

Jan 2022

Finished

Jul 2026

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 80 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: * Open fracture to arm, leg, or both * Over the age of 18 Exclusion Criteria: * Under the age of 18 * Allergy to tobramycin or any other antibiotic in the aminoglycoside family * Previously treated with a resorbable antibiotic carrier * Pregnancy

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Open Surgical Wound Infection Wound Infection

As listed by the trial registrant

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

Fractures, open Surgical site infection Wound infection

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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