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

Billy T. Haonga, MD; Patrick Ngunyale, MD; Ericka P. von Kaeppler, MD, PhD; Claire A. Donnelley, MD; Nae Y. Won, MPH; Edmund N. Eliezer, MD; Kelsey Brown, BA; Michael Flores, BS; Jamieson M. O'Marr, MS; Patricia Rodarte, BS; Mayur Urva, MD; Abigail Cortez, MD; Travis Porco, PhD; Saam Morshed, MD, MPH, PhD; David W. Shearer, MD, MPH

doi:10.1097/OI9.0000000000000268

OTA International (Jun 2023)

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

Billy T. Haonga, MD,
Patrick Ngunyale, MD,
Ericka P. von Kaeppler, MD, PhD,
Claire A. Donnelley, MD,
Nae Y. Won, MPH,
Edmund N. Eliezer, MD,
Kelsey Brown, BA,
Michael Flores, BS,
Jamieson M. O'Marr, MS,
Patricia Rodarte, BS,
Mayur Urva, MD,
Abigail Cortez, MD,
Travis Porco, PhD,
Saam Morshed, MD, MPH, PhD,
David W. Shearer, MD, MPH

Affiliations

Billy T. Haonga, MD: a Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania;
Patrick Ngunyale, MD: a Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania;
Ericka P. von Kaeppler, MD, PhD: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Claire A. Donnelley, MD: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Nae Y. Won, MPH: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Edmund N. Eliezer, MD: a Muhimbili Orthopaedic Institute, Dar es Salaam, Tanzania;
Kelsey Brown, BA: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Michael Flores, BS: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Jamieson M. O'Marr, MS: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Patricia Rodarte, BS: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Mayur Urva, MD: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Abigail Cortez, MD: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
Travis Porco, PhD: c Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.
Saam Morshed, MD, MPH, PhD: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and
David W. Shearer, MD, MPH: b Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco, San Francisco, CA; and

DOI: https://doi.org/10.1097/OI9.0000000000000268
Journal volume & issue: Vol. 6, no. 2

Abstract

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Abstract. 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.

Published in OTA International

ISSN: 2574-2167 (Online)
Publisher: Wolters Kluwer
Country of publisher: United States
LCC subjects: Medicine: Surgery: Orthopedic surgery
Website: https://journals.lww.com/otainternational/pages/default.aspx

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