Institute of Hygiene/Hospital Epidemiology, Medical Faculty of the University of Leipzig, Leipzig, Saxony, Germany.
Institute for Medical Informatics, Statistics and Epidemiology, Medical Faculty of the University of Leipzig, Leipzig, Saxony, Germany.
BMJ Open. 2017 Nov 8;7(11):e016251. doi: 10.1136/bmjopen-2017-016251.
Nosocomial infections are serious complications that increase morbidity, mortality and costs and could potentially be avoidable. Antiseptic body wash is an approach to reduce dermal micro-organisms as potential pathogens on the skin. Large-scale trials with chlorhexidine as the antiseptic agent suggest a reduction of nosocomial infection rates. Octenidine is a promising alternative agent which could be more effective against Gram-negative organisms. We hypothesise that daily antiseptic body wash with octenidine reduces the risk of intensive care unit (ICU)-acquired primary bacteraemia and ICU-acquired multidrug-resistant organisms (MDRO) in a standard care setting.
EFFECT is a controlled, cluster-randomised, double-blind study. The experimental intervention consists in using octenidine-impregnated wash mitts for the daily routine washing procedure of the patients. This will be compared with using placebo wash mitts. Replacing existing washing methods is the only interference into clinical routine.Participating ICUs are randomised in an AB/BA cross-over design. There are two 15-month periods, each consisting of a 3-month wash-out period followed by a 12-month intervention and observation period. Randomisation determines only the sequence in which octenidine-impregnated or placebo wash mitts are used. ICUs are left unaware of what mitts packages they are using.The two coprimary endpoints are ICU-acquired primary bacteraemia and ICU-acquired MDRO. Endpoints are defined based on individual ward-movement history and microbiological test results taken from the hospital information systems without need for extra documentation. Data on clinical symptoms of infection are not collected. EFFECT aims at recruiting about 45 ICUs with about 225 000 patient-days per year.
The study was approved by the ethics committee of the University of Leipzig (number 340/16-ek) in November 2016. Findings will be published in peer-reviewed journals.
DRKS-ID: DRKS00011282.
医院获得性感染是严重的并发症，会增加发病率、死亡率和医疗成本，而且这些感染在很大程度上是可以预防的。使用抗菌沐浴液是减少皮肤潜在病原体的一种方法。使用洗必泰作为抗菌剂的大规模试验表明，该方法可以降低医院获得性感染率。奥替尼定是一种很有前途的替代抗菌剂，它可能对革兰氏阴性菌更有效。我们假设，在标准护理环境中，每天使用奥替尼定抗菌沐浴液可以降低重症监护病房（ICU）获得性原发性菌血症和 ICU 获得性多药耐药菌（MDRO）的风险。
EFFECT 是一项对照、集群随机、双盲研究。实验组干预措施为使用奥替尼定浸渍的沐浴手套进行患者日常清洁程序，对照组为使用安慰剂浸渍的沐浴手套。这将与现有的清洁方法进行比较，研究中唯一的干预措施是更换现有的清洁方法。参与的 ICU 病房将按照 AB/BA 交叉设计进行随机分组。研究分为两个为期 15 个月的阶段，每个阶段包括 3 个月的洗脱期和 12 个月的干预和观察期。随机分组仅确定使用奥替尼定浸渍或安慰剂浸渍的沐浴手套的顺序，而 ICU 病房并不知道他们正在使用哪种手套。两个主要终点是 ICU 获得性原发性菌血症和 ICU 获得性 MDRO。终点是基于每个病房的移动历史和从医院信息系统中提取的微生物检测结果来定义的，无需额外的文件记录。未收集与感染临床症状相关的数据。EFFECT 旨在招募大约 45 个 ICU 病房，每年大约有 225000 个患者日。
该研究于 2016 年 11 月获得莱比锡大学伦理委员会的批准（编号 340/16-ek）。研究结果将发表在同行评议的期刊上。
DRKS-ID：DRKS00011282。
