Comparing gentamicin and saline for treating open tibia fractures
A Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia)
['FUNDING_OTHER'] · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · NIH-11061312
This study is looking at whether putting gentamicin directly on open tibia fractures can help prevent infections better than using a saltwater solution, and it's for patients with these types of injuries at the Muhimbili Orthopaedic Institute in Tanzania.
Quick facts
| Phase | ['FUNDING_OTHER'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (nih funded) |
| Locations | 1 site (SAN FRANCISCO, UNITED STATES) |
| Trial ID | NIH-11061312 on ClinicalTrials.gov |
What this research studies
This research investigates the effectiveness of locally applied gentamicin compared to saline in preventing infections in patients with open tibia fractures. The study will involve a pilot trial where participants will receive either gentamicin or a saline placebo directly in the wound. By focusing on local application, the research aims to achieve higher concentrations of the antibiotic at the fracture site, potentially improving healing outcomes. The trial will take place at the Muhimbili Orthopaedic Institute in Tanzania, where the incidence of open fractures and related infections is notably high.
Who could benefit from this research
Good fit: Ideal candidates for this research are adults aged 21 and older who have sustained an open tibia fracture.
Not a fit: Patients with closed tibia fractures or those who are not eligible for surgical intervention may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could significantly reduce the risk of infections and improve healing in patients with open tibia fractures.
How similar studies have performed: While local application of antibiotics has shown promise in other contexts, this specific approach with gentamicin in open tibia fractures is novel and has not been extensively tested.
Where this research is happening
SAN FRANCISCO, UNITED STATES
- UNIVERSITY OF CALIFORNIA, SAN FRANCISCO — SAN FRANCISCO, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: SHEARER, DAVID WILLIAM — UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- Study coordinator: SHEARER, DAVID WILLIAM
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.