Article Text
Abstract
Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
Trial registration number DRKS-ID: DRKS00011282.
- infection control
- epidemiology
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
AM and DH contributed equally.
Contributors IFC is the principal investigator of the study. AM and DH made substantial contributions to conception and design. DH is the responsible statistician. AM adapted the medical definition of the endpoints to the digital mode of data acquisition. AM wrote the first draft of the article; DH revised the first draft and contributed to the writing of the manuscript. IFC and OB revised it critically for important intellectual content. All authors approved the final submitted version of the manuscript.
Funding The study is funded by the Deutsche Forschungsgemeinschaft (German Research Foundation) (CH 1525/1-1). The manufacturer is paid factory costs for producing and providing the wash mitts (octenidine and placebo).
Competing interests None declared.
Ethics approval Ethics committee of the University of Leipzig (number 340/16-ek).
Provenance and peer review Not commissioned; externally peer reviewed.