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Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene (SIHAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588221
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
Non-inferiority in terms of reduction of bacterial counts will be investigated when combining the simpler three-step hand hygiene technique for the use of hand rub with a shorter application time of 15 seconds compared to the to the three steps technique with an application time of 30 seconds and the technique consisting in six steps.

Condition or disease Intervention/treatment Phase
Hand Hygiene Procedure: four sets of hand hygiene measurements per participant Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Randomized crossover trial, comparing the following four sets of hand hygiene measurements per participant:

  1. Six-step hand hygiene technique with an application time of 30 seconds
  2. Six-step hand hygiene technique with an application time of 15 seconds
  3. Three-step hand hygiene technique with an application time of 30 seconds
  4. Three-step hand hygiene technique with an application time of 15 seconds
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Simplifying the WHO Protocol for Hand Hygiene: Three Steps and 15 Seconds - a Randomized Cross-over Trial
Actual Study Start Date : July 16, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

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Arms and Interventions
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Arm Intervention/treatment
Six-step hand hygiene technique with application time of 30 Procedure: four sets of hand hygiene measurements per participant
  1. Six-step hand hygiene technique with an application time of 30 seconds
  2. Six-step hand hygiene technique with an application time of 15 seconds
  3. Three-step hand hygiene technique with an application time of 30 seconds
  4. Three-step hand hygiene technique with an application time of 15 seconds
Six-step hand hygiene technique with application time of 15 Procedure: four sets of hand hygiene measurements per participant
  1. Six-step hand hygiene technique with an application time of 30 seconds
  2. Six-step hand hygiene technique with an application time of 15 seconds
  3. Three-step hand hygiene technique with an application time of 30 seconds
  4. Three-step hand hygiene technique with an application time of 15 seconds
Three-step hand hygiene technique with application time of 3 Procedure: four sets of hand hygiene measurements per participant
  1. Six-step hand hygiene technique with an application time of 30 seconds
  2. Six-step hand hygiene technique with an application time of 15 seconds
  3. Three-step hand hygiene technique with an application time of 30 seconds
  4. Three-step hand hygiene technique with an application time of 15 seconds
Three-step hand hygiene technique with application time of 1 Procedure: four sets of hand hygiene measurements per participant
  1. Six-step hand hygiene technique with an application time of 30 seconds
  2. Six-step hand hygiene technique with an application time of 15 seconds
  3. Three-step hand hygiene technique with an application time of 30 seconds
  4. Three-step hand hygiene technique with an application time of 15 seconds


Outcome Measures
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Primary Outcome Measures :
  1. Change of bacterial counts on hands pre and post hand hygiene measure [ Time Frame: 30 minutes ]
    The log counts of bacteria detected on the dominant hand will be averaged separately for pre- and post values. Differences between pre- and post values, as well as in the mean logarithmic reduction in bacterial counts will be compared


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult participants (≥18 years)

Exclusion Criteria:

  • skin disorders as determined by a dermatologist
  • inability to follow procedures
  • insufficient knowledge of the project language
  • inability to give informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588221


Locations
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Switzerland
Division of Infectious Diseases and Hospital Epidemiology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Sarah Tschudin Sutter, PD MD University Hospital Basel, CH-4031 Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03588221    
Other Study ID Numbers: 2018-01049;me18Tschudin-Sutter
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No