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

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 - EFFECT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011282

Enrollment

Registered

2016-11-15

Start date

2017-01-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infection prevention on intensive care units

Interventions

Group 1: 1. daily bathing of all patients on the intensive care unit with octenidine-impregnated wash-cloths (15 months) 2. daily bathing of all patients on the intensive care unit with wash-cloths w

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
co-primary endpoints: 1. multidrug-resistant organisms (MDRO) that are acquired on intensive care units and 2. primary bacteriaemia that are acquired on intensive care units 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. The data will be transferred after each wash-out and each observation period respectively.	—

Measure

Time frame

co-primary endpoints: 1. multidrug-resistant organisms (MDRO) that are acquired on intensive care units and 2. primary bacteriaemia that are acquired on intensive care units 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. The data will be transferred after each wash-out and each observation period respectively.

—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactYasmine Breitenstein

ZKS Leipzig - KKS

yasmine.breitenstein@zks.uni-leipzig.de+49-341-97-16247

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 25, 2026