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EFFECT of daily antiseptic body wash with octenidine on nosocomial primary bacteraemia and nosocomial multidrug-resistant organisms in intensive care units: design of a multicentre, cluster-randomised, double-blind, cross-over study.

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.

SUBMITTER: Meißner A

PROVIDER: S-EPMC5695441 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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EFFECT of daily antiseptic body wash with octenidine on nosocomial primary bacteraemia and nosocomial multidrug-resistant organisms in intensive care units: design of a multicentre, cluster-randomised, double-blind, cross-over study.

Meißner Anne A Hasenclever Dirk D Brosteanu Oana O Chaberny Iris Freya IF

BMJ open 20171108 11

<h4>Introduction</h4>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 ...[more]

PMID: 29122787

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Project description:BackgroundProfessional hand hygiene compliance represents a multifaceted behaviour with various determinants. Thus, it has been proposed to apply psychological frameworks of behaviour change to its promotion. However, randomized controlled trials of such approaches, which also assess nosocomial infections (NIs), are rare. This study analyses data of the PSYGIENE-trial (PSYchological optimized hand hyGIENE promotion), which has shown improvements in compliance after interventions tailored based on the Health Action Process Approach (HAPA), on rates of NIs with multidrug-resistant organisms (MDROs).MethodsA parallel-group cluster-randomized controlled trial was conducted on all 10 intensive care units and two hematopoietic stem cell transplantation units at Hannover Medical School, a German tertiary care hospital. Educational training sessions for physicians and nurses (individual-level intervention) and feedback discussions with clinical managers and head nurses (cluster-level) were implemented in 2013. In the "Tailoring"-arm (n = 6 wards), interventions were tailored based on HAPA-components, which were empirically assessed and addressed by behaviour change techniques. As active controls, n = 6 wards received untailored educational sessions of the local "Clean Care is Safer Care"-campaign (Aktion Saubere Hände: "ASH"-arm). From 2013 to 2015 compliance was assessed by observation following the World Health Organization, while alcohol-based hand rub usage (AHRU) and NIs with multidrug-resistant gram-negative bacteria, Methicillin-resistant Staphylococcus aureus or Vancomycin-resistant Enterococcus were assessed following national surveillance protocols. Data were analysed at cluster-level.ResultsIn the "Tailoring"-arm, interventions led to a decrease of 0.497 MDRO-infections per 1000 inpatient days from 2013 to 2015 (p = 0.015). This trend was not found in the "ASH"-arm (- 0 . 022 infections; p = 0.899). These patterns corresponded inversely to the trends in compliance but not in AHRU.ConclusionsWhile interventions tailored based on the HAPA-model did not lead to a significantly lower incidence rate of MDRO-infections compared to control wards, a significant reduction, compared to baseline, was found in the second follow-up year in the "Tailoring"- but not the "ASH"-arm. This indicates that HAPA-tailored hand hygiene interventions may contribute to the prevention of NIs with MDRO. Further research should focus on addressing compliance by interventions tailored not only to wards, but also leaders, teams, and individuals.Trial registrationGerman Clinical Trials Register/International Clinical Trials Registry Platform, DRKS00010960. Registered 19 August 2016-Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010960. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00010960.

Dataset Information

EFFECT of daily antiseptic body wash with octenidine on nosocomial primary bacteraemia and nosocomial multidrug-resistant organisms in intensive care units: design of a multicentre, cluster-randomised, double-blind, cross-over study.

Publications

EFFECT of daily antiseptic body wash with octenidine on nosocomial primary bacteraemia and nosocomial multidrug-resistant organisms in intensive care units: design of a multicentre, cluster-randomised, double-blind, cross-over study.

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