Gentamicin Open Tibia Study
A Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures
University of California, San Francisco
890 participants
Sep 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Age>18 years old
- Open tibial shaft fracture meeting the following criteria:
- Orthopaed Trauma Association (OTA) Type 42
- Primarily closable wound
- Gustilo-Anderson (GA) Type I, II, or IIIA
Exclusion Criteria11
- 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
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Interventions
Liquid gentamicin administered at the open fracture site
Normal saline administered at the open fracture site
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05157126