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- Title
A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibia fractures.
- Authors
Haonga, Billy; Cortez, Abigail; von Kaeppler, Ericka P.; Donnelley, Claire A.; Brown, Kelsey; Flores, Michael; Eliezer, Edmund N.; Urva, Mayur; Shearer, David W.; Morshed, Saam
- Abstract
Background: Open tibial fractures have a high risk of infection that leads to chronic osteomyelitis, functional impairment, and limb loss. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there is limited data evaluating aminoglycoside antibiotics. Objective: To assess the feasibility of a clinical trial aimed to test the efficacy of local gentamicin in reducing the risk of fracture-related infection (FRI) after open tibial fracture. Methods: This study is a single-center pilot masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. All adult patients presenting with an open tibia fracture (Gustilo Anderson Types I, II or IIIA; OTA Type 42) were eligible for this study. Patients were excluded if time from injury to presentation was > 48 hours or time from injury to surgery was > 7 days. Participants were randomized intraoperatively after wound closure to receive gentamicin solution (treatment), or normal saline solution (control) injected at the fracture site. Patients, surgeons, outcome assessors, data collectors, and data analysts were all masked to treatment assignment. Follow-ups were completed at 2-weeks, 6-weeks, 3-months, 6- months, 9-months, and 1-year post-operatively. The primary feasibility outcomes were the rate of enrolment and retention. The primary clinical outcome was the occurrence of FRI. Secondary outcomes measured were the occurrence of non-union, unplanned fracture-related reoperations, EQ-5D score, FIX-IT sore, and modified RUST score. Results: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Most of the study population were male (80%) with an average age of 34 (SD 12.3). The primary mechanism was road traffic injury (85%). Complete data were recorded at baseline and follow up for >95% of cases The rate of follow up at 6-weeks, 3-months, 6-months, 9- months and 1 year were 70%, 68%, 69%, 61% and 80%, respectively. There was no difference in adverse events, or any of the measured primary and secondary outcomes. Conclusion: This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrolment and follow up to address this topic is possible in this setting. We, therefore, plan to proceed with a well-powered definitive trial.
- Subjects
COMPOUND fractures; GENTAMICIN; TIBIAL fractures; SALINE solutions; CLINICAL trials; BONE grafting; RESIDUAL limbs
- Publication
Tanzania Journal of Health Research, 2022, Vol 23, p25
- ISSN
1821-6404
- Publication type
Article