Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05157126 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Gentamicin Open Tibia Study

Study acronym: GO-Tibia
StatusRecruiting
PhasePhase 4
Started2022-09-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
3 amendments v4-v6
3 re-verifications since 2023-12-20, no change to tracked fields
2022-09-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04→confirmed 2022-09-01
Study sitesdetails revised at 1 of 1 site
2022-03-22
Study Status v2
Primary completion date2028-01→2028-04
Completion date2029-01→2029-04
Start date2022-01→2022-04
2022-01-11
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+62 characters
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 [...] pinal cord injury Severe vascular injury Severe burns (>10% Total Body Surface Area (TBSA) or >5% TBSA with full thickness or circumferential injury) [...]
Secondary endpoints6 entries, revised
Occurence of FRI Suggestive Criteria
2021-11-30
Original filing
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.
Trial Details
NCT Number NCT05157126
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
Conditions Fracture Open Tibia
Enrollment 890 participants
Start Date 2022-09-01
Primary Completion 2028-04 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-10