Gentamicin Open Tibia Study

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Fracture Open Tibia

In brief

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.

Key facts

Study ID

NCT05157126

Run by

University of California, San Francisco

People needed

890

Starts

2022-09-01

Expected to finish

2029-04-01

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Muhimbili Orthopaedic Institute — Dar es Salaam, Tanzania (enrolling)

Full record on ClinicalTrials.gov

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