N/A
N=100
Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania
Open Tibia Fracture
Bottom Line
View on ClinicalTrials.gov: NCT03559400 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Rate of Enrollment — 12.5 Participants enrolled per month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- local gentamicin injection (Drug); placebo saline injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Enrollment |
12.5 | — |
| PRIMARY Rate of Retention |
84 | — |
| PRIMARY Occurrence of Fracture-related Infection (FRI) |
9; 7 | — |
| SECONDARY Euro-Qol 5 Dimensions (EQ-5D) |
0.950; 0.938 | — |
| SECONDARY Modified Radiographic Union Scale for Tibial Fractures (mRUST) Score |
11.9; 12.0 | — |
| SECONDARY Function Index for Trauma (FIX-IT) Score |
10.9; 11.2 | — |
| SECONDARY Occurrence of Nonunion |
7; 6 | — |
| SECONDARY Occurrence of Fracture-related Reoperation |
3; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female patients age 18 or older
- Diagnosis of an acute open tibial shaft fracture meeting the following criteria:
- AO/OTA Type 42
- Primarily closable wound
- Type I, II, or IIIA Gustilo- Anderson (GA) Classification
Exclusion Criteria
- Time from injury to presentation > 48 hours
- Time from injury to surgery >7 days
- History of Aminoglycoside allergy
- GA IIIB or IIIC open fractures
- Bilateral open tibial fractures
- Severe brain (GCS 10% total body surface area (TBSA) or >5% TBSA with full thickness or circumferential injury)
- Pathologic fracture
- History of active limb infection, ipsilaterally
Data sourced from ClinicalTrials.gov (NCT03559400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.