- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102488
Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene: Three Steps and 15 Seconds (SIHAG II)
April 7, 2020 updated by: University Hospital, Basel, Switzerland
Simplifying Hand Hygiene Technique: Six Steps and 30 Seconds Versus Six Steps and 15 Seconds Versus Three Steps and 30 Seconds Versus Three Steps and 15 Seconds
This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Procedure: Six-step hand hygiene technique with an application time of 30 seconds
- Procedure: Six-step hand hygiene technique with an application time of 15 seconds
- Procedure: Three-step hand hygiene technique with an application time of 30 seconds
- Procedure: Three-step hand hygiene technique with an application time of 15 seconds
Detailed Description
The WHO guideline recommends 30 seconds for application of hand rub, however, mean bacterial reduction after 15 seconds of hand rubbing has been recently shown to be non-inferior and shortening application time to 15 seconds has been suggested to improve the frequency of hand hygiene actions in a neonatal care unit.
This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Basel, Switzerland, 4031
- Division of Infectious Diseases and Hospital Epidemiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 31 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Medical students are eligible for participation
- Signed informed consent
Exclusion Criteria:
- No signed informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 6-step hygiene technique, application time of 30 seconds
|
Six-step hand hygiene technique with an application time of 30 seconds
|
Experimental: 6-step hygiene technique, application time of 15 seconds
|
Six-step hand hygiene technique with an application time of 15 seconds
|
Experimental: 3-step hygiene technique, application time of 30 seconds
|
Three-step hand hygiene technique with an application time of 30 seconds
|
Experimental: 3-step hygiene technique, application time of 15 seconds
|
Three-step hand hygiene technique with an application time of 15 seconds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of bacterial counts on hands
Time Frame: 30 minutes
|
Change of bacterial counts on hands as determined by the mean logarithmic reduction in bacterial counts after performance of hand hygiene
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andreas Widmer, Prof. Dr. MD, University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2019
Primary Completion (Actual)
February 21, 2020
Study Completion (Actual)
February 21, 2020
Study Registration Dates
First Submitted
September 24, 2019
First Submitted That Met QC Criteria
September 24, 2019
First Posted (Actual)
September 25, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2020
Last Update Submitted That Met QC Criteria
April 7, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2019-01518; me19Widmer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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