Using Tobramycin Injection to Prevent Infections in Open Fractures
Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?
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 |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Lexington, Kentucky and 2 other locations) |
| Trial ID | NCT04964947 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over the age of 18 with an open fracture to the arm or leg.
Not a fit: Patients under 18, those with allergies to tobramycin or aminoglycosides, and pregnant individuals may not benefit from this study.
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 performed: Previous studies have shown promise in using local antibiotics for infection prevention in surgical settings, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Lexington, Kentucky and 2 other locations
- University of Kentucky — Lexington, Kentucky, United States (Active_not_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.