Gentamicin Open Tibia Study (GO-Tibia)
Fracture Open Tibia
About this trial
This is an interventional prevention trial for Fracture Open Tibia
Eligibility Criteria
Inclusion Criteria:
- 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 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
Sites / Locations
- Muhimbili Orthopaedic InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Gentamicin
Saline
The intervention consists of 80mg of liquid gentamicin diluted in 5 mL normal saline (16mg/mL). The solution is injected by inserting a 22-gauge needle down to bone through an anteromedial approach at the level of the fracture site such that the injected solution fills the wound cavity. A total of 5mL of study solution will be administered.
The control consists of 5 mL normal saline injected immediately after wound closure at the open fracture site. The solution is injected by inserting a 22-gauge needle down to bone through an anteromedial approach at the level of the fracture site such that the injected solution fills the wound cavity. A total of 5mL of study solution will be administered.