Gentamicin Open Tibia Study

• Status: Not yet recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Muhimbili Orthopaedic Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Orthopedic Research and Education Foundation
• Treatments: Gentamicins

Criteria

Inclusion Criteria:

• Age>18 years old

• Open tibial shaft fracture meeting the following criteria:

1. OTA Type 42

2. Primarily closable wound

3. Gustilo-Anderson 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% TBSA or >5% TBSA with full thickness or circumferential injury)

• Pathologic fracture

• History of active limb infection, ipsilaterally

• Unlikely to complete follow-up