背景:治疗开放性骨折的一大挑战是术后感染,在Gustilo-AndersonIII型骨折中发病率较高。在发展中国家,此类骨折的明确治疗通常是使用外固定器,并伴有并发症,如深部骨折相关感染,非工会,从而提高了再次手术率。最近,有一种新的方法可以使用抗生素水泥涂层植入物,如髓内钉和锁定钢板治疗感染的非愈合,据报道效果良好.该协议旨在描述假设,目标,一项随机对照试验的设计和统计分析,该试验比较了在Gustilo-AndersonIII型长骨骨折治疗中使用抗生素-水泥涂层钢板和外固定支架的感染率。
方法:这是一个多中心,开放标签,平行组,优越性,随机化,对照试验。所有在急诊科就诊的III型长骨骨折患者将被筛选入组,只有那些符合纳入标准的患者将被登记参加研究。患者将使用集中的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部固定组。主要结果将是在一年随访期间的任何时间发生感染,这将对每个患者计数一次。次要结果是工会率,从基线到随访结束,再次手术率和健康相关生活质量(HRQoL)的变化。分析将使用R(R核心团队,2023年)和Rstudio(Rstudio团队,2023年)。
结论: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钢板可有效降低感染率。在发展中国家,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钢板的感染率存在显着差异。
背景:研究方案已在临床试验中注册,gov(NCT06193330)。
BACKGROUND: 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.
METHODS: 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).
CONCLUSIONS: 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.
BACKGROUND: The
study protocol is registered with ClinicalTrials,gov (NCT06193330).