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GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures
Billy T Haonga1, Jamieson M O'Marr2, Patrick Ngunyale1
1Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Trials
|June 15, 2023
Summary
This study investigates local gentamicin for preventing infections in open tibia fractures, a growing global concern. Results could offer a low-cost intervention to reduce fracture-related infections in Tanzania.
Area of Science:
- Orthopedic Surgery
- Infectious Disease Prevention
- Global Health
Background:
- Open tibia fractures are increasing globally, particularly in low-resource settings, due to road traffic accidents.
- These fractures carry high infection risks (up to 40%) despite standard treatments like antibiotics and debridement.
- Existing research on local antibiotics is limited, often from high-resource countries with different patient populations and healthcare systems.
Purpose of the Study:
- To definitively assess the effectiveness of locally administered gentamicin in preventing fracture-related infections.
- To evaluate a potentially low-cost and widely available intervention for a common orthopedic emergency.
Main Methods:
- A prospective, randomized, masked, placebo-controlled superiority trial involving 890 adult patients.
- Participants have primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures.
- The primary outcome is the occurrence of fracture-related infection within a 12-month follow-up period, comparing gentamicin injection to a saline placebo.
Main Results:
- This section is not yet available as the study is ongoing.
Conclusions:
- The study aims to provide definitive evidence on local gentamicin's efficacy for open tibia fracture infection prevention in Tanzania.
- Findings have the potential to introduce a cost-effective intervention to reduce infection rates in this vulnerable patient group.
