Department of Orthopaedics and Trauma, University College Hospital, Ibadan, Nigeria.
Department of Orthopaedics and Trauma, University College Hospital, Ibadan, Nigeria.
Injury. 2024 Aug;55(8):111637. doi: 10.1016/j.injury.2024.111637. Epub 2024 May 28.
One of the great challenges in the management of open fractures is postoperative infection with a higher incidence in Gustilo-Anderson type III fractures. Definitive management of such fractures in developing countries is usually with external fixators with its attendant complications such as deep fracture-related infection, non-union, and consequent increased re-operation rates. Recently, there has been a novel method of using antibiotic-cement coated implants such as intramedullary nails and locking plates in the treatment of infected non-unions with reported excellent outcomes. This protocol aims to describe the hypothesis, objectives, design and statistical analysis of a randomized control trial that compares the infection rate between the use of antibiotics-cement coated plate and external fixation in the management of Gustilo-Anderson type III long bone fractures.
This is a multicentre, open-label, parallel group, superiority, randomized, control trial. All patients with type III long bone fractures who present at the emergency department will be screened for enrolment and only those patients that meet the inclusion criteria will be registered for the study. Patients will be randomized using a centralized 24-hr computerized randomization system into two groups: antibiotic-cement coated plate group and the external fixation group. The primary outcome will be occurrence of infection at any time during the course of one year follow-up which will be counted once for each of the patients. The secondary outcomes are union rate, re-operation rate and change in Health Related Quality of Life (HRQoL) from baseline to end of follow-up. Analysis will be done using R (R Core Team, 2023) and Rstudio (Rstudio Team, 2023).
Literature has shown that use of antibiotic-coated plate in the management of severe open long bone fractures is effective in reducing infection rate. A significant difference in infection rate with use of antibiotic-cement coated plate compared to use of external fixator for open fractures will be a welcome intervention in developing countries.
The study protocol is registered with ClinicalTrials,gov (NCT06193330).
开放性骨折管理中的一大挑战是术后感染，尤其是 Gustilo-Anderson Ⅲ型骨折。在发展中国家，此类骨折的确定性治疗通常采用外固定器，其伴随的并发症包括深部骨折相关感染、不愈合，以及随之而来的再手术率增加。最近，有一种新的方法使用抗生素-水泥涂层植入物，如髓内钉和锁定板，治疗感染性骨不连，报告的结果非常出色。本方案旨在描述一项随机对照试验的假设、目的、设计和统计分析，该试验比较了在 Gustilo-Anderson Ⅲ型长骨骨折治疗中使用抗生素-水泥涂层板与外固定的感染率。
这是一项多中心、开放标签、平行组、优效性、随机、对照试验。所有在急诊科就诊的 III 型长骨骨折患者均进行筛查以纳入研究，只有符合纳入标准的患者才会被登记入组。患者将使用集中式 24 小时计算机随机化系统随机分为两组：抗生素-水泥涂层板组和外固定组。主要结局是在为期 1 年的随访过程中任何时候发生感染，每位患者将计算 1 次。次要结局是愈合率、再手术率和基线至随访结束时健康相关生活质量（HRQoL）的变化。分析将使用 R（R Core Team, 2023）和 Rstudio（Rstudio Team, 2023）进行。
文献表明，在严重开放性长骨骨折的治疗中使用抗生素涂层板可有效降低感染率。与使用外固定器治疗开放性骨折相比，使用抗生素-水泥涂层板的感染率有显著差异，这将是发展中国家受欢迎的干预措施。
该研究方案在 ClinicalTrials.gov 上注册（NCT06193330）。
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