A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).

Autor:	Haonga BT; Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania., Ngunyale P; Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania., von Kaeppler EP; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Donnelley CA; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Won NY; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Eliezer EN; Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania., Brown K; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Flores M; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., O'Marr JM; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Rodarte P; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Urva M; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Cortez A; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Porco T; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA., Morshed S; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and., Shearer DW; Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and.
Jazyk:	angličtina
Zdroj:	OTA international : the open access journal of orthopaedic trauma [OTA Int] 2023 Mar 27; Vol. 6 (2), pp. e268. Date of Electronic Publication: 2023 Mar 27 (Print Publication: 2023).
DOI:	10.1097/OI9.0000000000000268
Abstrakt:	Background: Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture. Methods: This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection. Results: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). 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 enrollment and follow-up to address this topic is possible in this setting. Competing Interests: The authors have no conflicts of interest to disclose (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.)
Databáze:	MEDLINE
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