%0 Journal Article
%T A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).
%A Haonga BT
%A Ngunyale P
%A von Kaeppler EP
%A Donnelley CA
%A Won NY
%A Eliezer EN
%A Brown K
%A Flores M
%A O'Marr JM
%A Rodarte P
%A Urva M
%A Cortez A
%A Porco T
%A Morshed S
%A Shearer DW
%J OTA Int
%V 6
%N 2
%D 2023 Jun
%M 37719315
暂无%R 10.1097/OI9.0000000000000268
%X <B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.