Karolinska Institutet Institutionen för kliniska vetenskaper Danderyds sjukhus, Danderyd, Sweden
Department of Clinical Sciences, Lund University, Lund, Sweden.
BMJ Open. 2022 Feb 3;12(2):e047500. doi: 10.1136/bmjopen-2020-047500.
There is controversy regarding the importance of air-transmitted infections for surgical site infections (SSIs) after orthopaedic surgery. Research has been hindered by both the inability in blinding the exposure, and by the need for recruiting large enough cohorts. The aim of this study is to investigate whether using a new form of air purifier using plasma air purification (PAP) in operating rooms (ORs) lowers the SSI rate or not.
Multicentre, double-blind, cluster-randomised, placebo-controlled trial conducted at seven hospitals in 2017-2022. All patients that undergo orthopaedic surgery for minimum 30 min are included. Intervention group: patients operated in OR with PAP devices turned on.
patients operated in OR with PAP devices turned off. Randomisation: each OR will be randomised in periods of 4 weeks, 6 weeks or 8 weeks to either have the devices on or off.
any SSI postoperatively defined as a composite endpoint of any of the following: use of isoxazolylpenicillin, clindamycin or rifampicin for 2 days or more, International Classification of Diseases codes or Nordic Medico-Statistical Committee codes indicating postoperative infection. In a second step, we will perform a chart review on those patients with positive indicators of SSI to further validate the outcome. Secondary outcomes are described in the Methods section. Power: we assume an SSI rate of 2%, an SSI reduction rate of 25% and we need approximately 45 000 patients to attain a power of 80% at a significance level of 0.05.
The study is approved by the Swedish Ethical Review Authority. The interim analysis results from the study will be presented only to the researchers involved unless the study thereafter is interrupted for whatever reason. Publication in a medical journal will be presented after inclusion of the last patient.
NCT02695368.
关于空气传播感染对骨科手术后手术部位感染（SSI）的重要性，存在争议。由于无法对暴露进行盲法处理，以及需要招募足够大的队列，研究受到了阻碍。本研究旨在探讨在手术室（OR）中使用新型等离子空气净化（PAP）空气净化器是否降低 SSI 率。
2017 年至 2022 年在 7 家医院进行的多中心、双盲、整群随机、安慰剂对照试验。所有接受骨科手术时间至少 30 分钟的患者均纳入研究。干预组：在 PAP 设备开启的 OR 中接受手术的患者。对照组：在 PAP 设备关闭的 OR 中接受手术的患者。随机分组：每个 OR 将在 4 周、6 周或 8 周的时间段内随机分为设备开启或关闭。
术后任何 SSI 定义为以下任何一种的复合终点：使用异恶唑青霉素、克林霉素或利福平超过 2 天，国际疾病分类或北欧医学统计委员会代码表明术后感染。在第二步中，我们将对那些具有 SSI 阳性指标的患者进行病历回顾，以进一步验证该结果。次要结局在方法部分描述。
我们假设 SSI 发生率为 2%，SSI 降低率为 25%，需要大约 45000 名患者才能在 80%的功效和 0.05 的显著性水平下达到功效。
该研究已获得瑞典伦理审查局的批准。只有在研究因任何原因中断的情况下，研究的中期分析结果才会提交给参与的研究人员，否则将在最后一名患者纳入后公布在医学期刊上。
NCT02695368。
