Gentamicin Open Tibia Study
Recruiting
Phase 4
Interventional Study
Fracture Open Tibia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 890 (estimated)
- Sponsor
- University of California, San Francisco · Other
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About This Trial
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, loca…
Trial Locations
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Eligibility 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
* T…
Contacts