Trial document




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  DRKS00011282

Trial Description

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Title

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

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Trial Acronym

EFFECT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

On intensive care units (ICU) patients will be washed on a daily basis. In the EFFECT-trial two washing methods are compared. Therefore, for 15 months, patients on the participating ICU patients will be washed with desinfectant impregnated wash-cloths or with wash-cloths that are not desinfectant.

After 15 months the other type of wash-cloths will be used. The order in which the different types of wash-cloths will be used, is determined by chance (randomisation).

Both types of wash-cloths are already used in the daily routine of ICUs.

Therefore, the trial recruits intensive care units as observation units and not single patients.

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Brief Summary in Scientific Language

EFFECT wants to investigate, if washing with octenidine-impregnated wash-cloths (verum), compared to wash-cloths without active component (placebo), reduces the risk of proven nosokomial pathogens in a standard care setting.

EFFECT is a multicentre, controlled, cluster-randomized, double-blind, AB-BA-Cross-over study. The participating intensive care units are randomised in a cross-over manner to outhweigh period effects (secular trends).

The study intervention only consists of the use of disinfectant, with octenidine-impregnated wash-cloths for the daily routine bathing of patients, compared to using a wash-cloth without antiseptic.

Therefore, the trial recruits intensive care units as observation units and not single patients.

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Organizational Data

  •   DRKS00011282
  •   2016/11/15
  •   [---]*
  •   yes
  •   Approved
  •   340/16-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   infection prevention on intensive care units
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Interventions/Observational Groups

  •   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 without antiseptic (15 months)
  •   1. daily bathing of all patients on the intensive care unit with wash-cloths without antiseptic (15 months)

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

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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, caregiver, data analyst
  •   Placebo
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/01/01
  •   45
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   [---]*
  •   [---]*   [---]*
  •   [---]*   [---]*
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Additional 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

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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

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Addresses

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    • Universitätsklinikum Leipzig, Institut für Hygiene, Krankenhaushygiene und Umweltmedizin
    • Ms.  Prof. Dr. med.  Iris F.  Chaberny 
    • Johannisallee 34, Haus L
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig, Institut für Hygiene, Krankenhaushygiene und Umweltmedizin
    • Ms.  Prof. Dr. med.  Iris F.  Chaberny 
    • Johannisallee 34, Haus L
    • 04103  Leipzig
    • Germany
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    • ZKS Leipzig - KKS
    • Ms.  Yasmine  Breitenstein 
    • Haertelstr. 16-18
    • 04107  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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