Using Tobramycin Injection to Prevent Infections in Open Fractures
Official title: Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?
Run by Massachusetts General Hospital · NCT04964947 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests whether using Tobramycin injections directly at the site of open fractures can help prevent infections and improve healing for patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Lexington, Kentucky and 2 other locations) |
| Trial ID | NCT04964947 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over the age of 18 with an open fracture to the arm or leg.
✕Probably not a fit
Patients under 18, those with allergies to tobramycin or aminoglycosides, and pregnant individuals may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of Tobramycin injection as a local antibiotic treatment to prevent infections in patients with open extremity fractures. The approach focuses on delivering high concentrations of the antibiotic directly to the wound site, addressing the limitations of systemic antibiotics that may not adequately penetrate poorly vascularized areas. The study aims to evaluate the effectiveness of this local administration in reducing infection rates and promoting better healing outcomes. Participants will be monitored for infection rates and overall recovery following the intervention.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce infection rates in patients with open fractures, leading to improved healing and recovery.
How similar studies have gone: Previous studies have shown promise in using local antibiotics for infection prevention in surgical settings, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting -
University of Kentucky
Lexington, Kentucky, United States Active not recruiting
Study contacts
- Principal investigator: Arun Aneja, MD, PhD — Massachusetts General Hospital
- Study coordinator: Arun Aneja, MD, PhD
- Email: aaneja@mgh.harvard.edu
- Phone: 617-726-6546
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.