PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■开放性胫骨骨折具有很高的感染风险，可导致严重的发病率。在开放性伤口部位局部施用抗生素是一种潜在的有效预防措施，但是评估氨基糖苷类抗生素的数据有限。这项研究的目的是评估一项临床试验的可行性，以测试局部庆大霉素降低开放性胫骨骨折后骨折相关感染的风险。
■这项研究是一个单中心，飞行员,蒙面,在Muhimbili骨科研究所进行的随机对照试验.在伤口闭合后，参与者在术中随机接受庆大霉素溶液或在骨折部位注射生理盐水溶液。随访在2周完成，6周,3个月,6个月,9个月,术后1年。主要可行性结果是入学率和保留率。主要临床结果是骨折相关感染的发生。
■在接受筛查的199名患者中，100名符合条件的患者成功入选，并在9个月内随机分组（11.1名患者/月）。在基线和随访时记录了>95％的病例的完整数据。6周随访率,3个月,6个月,9个月,一年是70%，68%,69%,61%,80%,分别。不良事件或任何测量的主要和次要结局没有差异。
■这项初步研究是首次评估局部使用庆大霉素治疗胫骨开放性骨折的研究之一。结果表明，在这种情况下，可以进行严格的临床试验，可接受的入学率和随访以解决该主题。
■这项研究是一个单中心，飞行员,蒙面,在Muhimbili骨科研究所进行的随机对照试验.在伤口闭合后，参与者在术中随机接受庆大霉素溶液或在骨折部位注射生理盐水溶液。随访在2周完成，6周,3个月,6个月,9个月,术后1年。主要可行性结果是入学率和保留率。主要临床结果是骨折相关感染的发生。
■在接受筛查的199名患者中，100名符合条件的患者成功入选，并在9个月内随机分组（11.1名患者/月）。在基线和随访时记录了>95％的病例的完整数据。6周随访率,3个月,6个月,9个月,一年是70%，68%,69%,61%,80%,分别。不良事件或任何测量的主要和次要结局没有差异。
■这项初步研究是首次评估局部使用庆大霉素治疗胫骨开放性骨折的研究之一。结果表明，在这种情况下，可以进行严格的临床试验，可接受的入学率和随访以解决该主题。
