高剂量抗生素骨水泥对股骨颈骨折行髋关节半髋关节置换术后手术部位感染率的影响：一项双盲拟随机对照试验方案。
The effect of high dose antibiotic impregnated cement on rate of surgical site infection after hip hemiarthroplasty for fractured neck of femur: a protocol for a double-blind quasi randomised controlled trial.
机构信息
Warwick Medical School, The University of Warwick, Coventry CV4 7AL, UK.
出版信息
BMC Musculoskelet Disord. 2013 Dec 17;14:356. doi: 10.1186/1471-2474-14-356.
BACKGROUND
Mortality following hip hemiarthroplasty is in the range of 10-40% in the first year, with much attributed to post-operative complications. One such complication is surgical site infection (SSI), which at the start of this trial affected 4.68% of patients in the UK having this operation. Compared to SSI rates of elective hip surgery, at less than 1%, this figure is elevated. The aim of this quasi randomised controlled trial (RCT) is to determine if high dose antibiotic impregnated cement can reduce the SSI in patients at 12-months after hemiarthroplasty for intracapsular fractured neck of femur.
METHODS
848 patients with an intracapsular fractured neck of femur requiring a hip hemiarthroplasty are been recruited into this two-centre double-blind quasi RCT. Participants were recruited before surgery and quasi randomised to standard care or intervention group. Participants, statistician and outcome assessors were blind to treatment allocation throughout the study. The intervention consisted of high dose antibiotic impregnated cement consisting of 1 gram Clindamycin and 1 gram of Gentamicin. The primary outcome is Health Protection Agency (HPA) defined deep surgical site infection at 12 months. Secondary outcomes include HPA defined superficial surgical site infection at 30 days, 30 and 90-day mortality, length of hospital stay, critical care stay, and complications.
DISCUSSION
Large randomised controlled trials assessing the effectiveness of a surgical intervention are uncommon, particularly in the speciality of orthopaedics. The results from this trial will inform evidence-based recommendations for antibiotic impregnated cement in the management of patients with a fractured neck of femur undergoing a hip hemiarthroplasty. If high dose antibiotic impregnated cement is found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip hemiarthroplasty.
TRIAL REGISTRATION
Current Controlled Trials: ISRCTN25633145.
背景
髋关节半髋关节置换术后的 1 年死亡率为 10-40%，其中大部分归因于术后并发症。其中一种并发症是手术部位感染（SSI），在本试验开始时，英国接受该手术的患者中有 4.68%受到影响。与择期髋关节手术的 SSI 发生率（低于 1%）相比，这一数字偏高。本准随机对照试验（RCT）的目的是确定高剂量抗生素浸渍水泥是否能降低 12 个月后因囊内股骨颈骨折而行半髋关节置换术患者的 SSI。
方法
848 例囊内股骨颈骨折需行髋关节半髋关节置换术的患者被纳入本中心双盲准 RCT。参与者在手术前招募，并被准随机分配至标准护理组或干预组。参与者、统计学家和结果评估者在整个研究过程中对治疗分配均不知情。干预措施包括高剂量抗生素浸渍水泥，其中含有 1 克克林霉素和 1 克庆大霉素。主要结局是 12 个月时健康保护局（HPA）定义的深部手术部位感染。次要结局包括 HPA 定义的 30 天、30 天和 90 天死亡率、住院时间、重症监护时间以及并发症。
讨论
评估手术干预效果的大型随机对照试验并不常见，特别是在矫形外科领域。该试验的结果将为抗生素浸渍水泥在管理股骨颈骨折患者行髋关节半髋关节置换术中的应用提供循证建议。如果高剂量抗生素浸渍水泥被发现是一种有效的干预措施，那么将其纳入临床实践可能会改善接受髋关节半髋关节置换术的患者的长期结局。
试验注册
当前对照试验：ISRCTN25633145。
Zotero 插件