EFFECT of daily washing of patients with Octenidine impregnated wash-cloths on intensive care units on nosocomial infections – a randomised, double-blind, cross-over trial

Not Applicable

• Conditions: infection prevention on intensive care units

• Registration Number: DRKS00011282
• Lead Sponsor: niversitätsklinikum Leipzig, Institut für Hygiene, Krankenhaushygiene und Umweltmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-15
• Study Completion: 2021-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. In general, (e.g. 90%), patients on the ICU are overall washed by nursing staff on a daily basis. ICUs, where a relevant part of the patients are entirely washing themselves or may not be washed, may not participate.
2. MRDO-Screening SOPs are in force
3. all individual and microbiological data can be made electronically available

Exclusion Criteria

1. ICU with specialisation on burn patients, because in these patients a comprehensive washing is contraindicated.
2. ICU with specialisation on bone marrow transplants, because these patients are often mobile and wash themselves
3. paediatric ICUs, because the test product is only to be used after the age of 3.
4. Participation in other (investigative) projects that interfere with the endpoints of EFFECT (assessment by the coordinating investigator)
5. Restructuring activities on the ICU or in the hospital in the next 3 years. (assessment by the coordinating investigator)
Examples:
5a) planned major changes of patient groups
5b) planned change of MRDO screening procedures
5c) planned change of microbiological laboratory

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
co-primary endpoints:<br>1. multidrug-resistant organisms (MDRO) that are acquired on intensive care units and 2. primary bacteriaemia that are acquired on intensive care units<br><br>The endpoints are calculated with movement data in combination with the microbiological findings to generate intensive care unit episodes that will be rated on the basis of an algorithm.<br><br>The data will be transferred after each wash-out and each observation period respectively.

Secondary Outcome Measures

Name	Time	Method
to 1st co-primary endpoint: <br>1a) on Intensive care unit (ICU) acquired MRSA<br>1b) on ICU acquired VRE<br>1c) on ICU acquired MRGN<br><br>to 2nd co-primary endpoint:<br>2a) on ICU acquired primary bacteriaemia with pathogen<br>2b) on ICU acquired primary bacteriaemia with grampositive pathogen<br>2c) on ICU acquired primary bacteriaemia with gramnegative pathogen<br>2d) on ICU acquired primary bacteriaemia with common skin pathogen<br>2e) on ICU acquired primary or secondary bacteriaemia