A randomised control trial investigating the effect of improving the cleaning of shared medical equipment on healthcare-associated infections (The CLEEN study): Statistical Analysis Plan

This document outlines the Statistical Analysis Plan for the CLEaning and Enhanced disiNfection (CLEEN) study. The CLEaning and Enhanced disiNfection (CLEEN) study is a stepped wedge cluster randomised trial evaluating the role of enhanced cleaning and disinfection of shared medical equipment as part of hospital infection prevention and control programs. The study is preregistered with the Australian and New Zealand Clinical Trials Registry (ACTRN12622001143718) and is funded by the National Health and Medical Research Council (GNT2008392). The full study protocol used to inform the Statistical Analysis Plan has been published.[1][1] A signed copy of the Statistical Analysis Plan is available on request from the corresponding author (BM). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ACTRN12622001143718 ### Clinical Protocols ### Funding Statement This project is funded by an NHMRC Emerging Leadership Investigator grant (Prof Brett Mitchell), (GNT2008392), administered by Avondale University. ACTRN12622001143718. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Hunter New England Human Research Ethics Committee gave ethical approval for this work (HREA: 2022/ETH01780) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors * HAI : Healthcare-associated infection GLMM : Generalised linear mixed model AIC : Akaike’s Information Criterion ECDC : European Centre for Disease Prevention and Control CLEEN : CLEaning and Enhanced disiNfection BSI : Bloodstream infection UTI : Urinary tract infection PN : Pneumonia SSI : Surgical site infection EENT : Ear, eye, nose, mouth and throat [1]: #ref-1