Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania

• Status: Active, not recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This pilot study aims to assess feasibility of a randomized controlled trial 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: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Muhimbili Orthopaedic Institute
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Gentamicins

Criteria

Inclusion Criteria:

1. Male or female patients age 18 or older

2. Diagnosis of an acute open tibial shaft fracture meeting the following criteria:

1. AO/OTA Type 42

2. Primarily closable wound

3. Type I, II, or IIIA Gustilo- Anderson (GA) Classification

Exclusion Criteria:

1. Time from injury to presentation > 48 hours

2. Time from injury to surgery >7 days

3. History of Aminoglycoside allergy

4. GA IIIB or IIIC open fractures

5. Bilateral open tibial fractures

6. Severe brain (GCS<12) or spinal cord injury

7. Severe vascular injury

8. Sustained severe burns (>10% total body surface area (TBSA) or >5% TBSA with full thickness or circumferential injury)

9. Pathologic fracture

10. History of active limb infection, ipsilaterally