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Gentamicin Open Tibia Study

NCT05157126 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 890

Last updated 2025-04-10

No results posted yet for this study

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.

Conditions

  • Fracture Open Tibia

Interventions

DRUG

Gentamicin

Liquid gentamicin administered at the open fracture site

DRUG

normal Saline

Normal saline administered at the open fracture site

Sponsors & Collaborators

  • Muhimbili Orthopaedic Institute

    collaborator OTHER

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • David W Shearer, MD, MPH · University of California, San Francisco

  • Billy T Haonga, MD · Muhimbili Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • Tanzania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05157126 on ClinicalTrials.gov