Actively Recruiting
Gentamicin Open Tibia Study
Led by University of California, San Francisco · Updated on 2025-04-10
890
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
M
Muhimbili Orthopaedic Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Local application of antibiotics directly to the traumatic wound is a promising treatment for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This study aims to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania. If proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.
CONDITIONS
Official Title
Gentamicin Open Tibia Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Open tibial shaft fracture classified as Orthopaedic Trauma Association Type 42
- Wound that can be primarily closed
- Gustilo-Anderson Type I, II, or IIIA open fracture
You will not qualify if you...
- Injury occurred more than 48 hours before presentation
- Surgery delayed more than 7 days after injury
- Allergy to aminoglycoside antibiotics
- Gustilo-Anderson Type IIIB or IIIC open fractures
- Open fractures in both tibias (bilateral)
- Severe brain injury with Glasgow Coma Scale less than 12
- Severe spinal cord injury
- Severe vascular injury
- Severe burns covering more than 10% of the body surface area or more than 5% with full thickness or circumferential injury
- Pathologic fracture
- History of active infection in the affected limb
- Unlikely to complete follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Muhimbili Orthopaedic Institute
Dar es Salaam, Tanzania
Actively Recruiting
Research Team
D
David W Shearer, MD, MPH
CONTACT
T
Tigist Belaye, MPA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here