Local gentamicin application for preventing infection in open tibia fractures
A Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures
This study is testing if putting gentamicin directly on open tibia fractures can help prevent infections better than just using saline in patients in Tanzania.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 890 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Dar es Salaam) |
| Trial ID | NCT05157126 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of locally applied gentamicin in preventing infection in patients with open tibial fractures in Tanzania. Open tibial fractures are prone to infection and complications, which can lead to significant disability. The trial aims to determine if gentamicin, applied directly to the wound, can reduce the risk of fracture-related infections compared to standard saline treatment. This is the first randomized trial of its kind, and if successful, it could provide a cost-effective strategy for managing these injuries globally.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with specific types of open tibial shaft fractures that are primarily closable.
Not a fit: Patients with severe open fractures, significant comorbidities, or those who present too late after injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infection and complications from open tibial fractures, improving patient outcomes.
How similar studies have performed: While local application of antibiotics has been explored, this is the first high-quality clinical trial specifically evaluating gentamicin for this purpose, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\>18 years old * Open tibial shaft fracture meeting the following criteria: 1. Orthopaed Trauma Association (OTA) Type 42 2. Primarily closable wound 3. Gustilo-Anderson (GA) Type I, II, or IIIA Exclusion Criteria: * Time from injury to presentation \> 48 hours * Time from injury to surgery \> 7 days * Aminoglycoside allergy * GA IIIB or IIIC open fractures * Bilateral open tibial fractures * Severe brain (GCS\<12) or spinal cord injury * Severe vascular injury * Severe burns (\>10% Total Body Surface Area (TBSA) or \>5% TBSA with full thickness or circumferential injury) * Pathologic fracture * History of active limb infection, ipsilaterally * Unlikely to complete follow-up
Where this trial is running
Dar es Salaam
- Muhimbili Orthopaedic Institute — Dar es Salaam, Tanzania (Recruiting)
Study contacts
- Principal investigator: David W Shearer, MD, MPH — University of California, San Francisco
- Study coordinator: David W Shearer, MD, MPH
- Email: david.shearer@ucsf.edu
- Phone: 628-206-8812
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.