Hand HygieneSIHAG IINCT04102488
Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene: Three Steps and 15 Seconds
A study testing Six-step hand hygiene technique with an application time of 30 seconds, Six-step hand hygiene technique with an application time of 15 seconds and Three-step hand hygiene technique with an application time of 30 seconds in people with Hand Hygiene, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 31 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- Six-step hand hygiene technique with an application time of 30 seconds, Six-step hand hygiene technique with an application time of 15 seconds and Three-step hand hygiene technique with an application time of 30 seconds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2019to 21 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 31 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical students are eligible for participation
- Signed informed consent
Who cannot join
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Infectious Diseases and Hospital Epidemiology
Basel, 4031
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Hygiene
- Being tested
- Six-step hand hygiene technique with an application time of 30 seconds, Six-step hand hygiene technique with an application time of 15 seconds, Three-step hand hygiene technique with an application time of 30 seconds, Three-step hand hygiene technique with an application time of 15 seconds
- Keywords
- reduction of bacterial counts, hand hygiene technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six-step hand hygiene technique with an application time of 30 secondsProcedure or surgery
Six-step hand hygiene technique with an application time of 30 seconds
Six-step hand hygiene technique with an application time of 15 secondsProcedure or surgery
Six-step hand hygiene technique with an application time of 15 seconds
Three-step hand hygiene technique with an application time of 30 secondsProcedure or surgery
Three-step hand hygiene technique with an application time of 30 seconds
Three-step hand hygiene technique with an application time of 15 secondsProcedure or surgery
Three-step hand hygiene technique with an application time of 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| 6-step hygiene technique, application time of 30 seconds | Experimental | Not described Receives: Procedure: Six-step hand hygiene technique with an application time of 30 seconds |
| 6-step hygiene technique, application time of 15 seconds | Experimental | Not described Receives: Procedure: Six-step hand hygiene technique with an application time of 15 seconds |
| 3-step hygiene technique, application time of 30 seconds | Experimental | Not described Receives: Procedure: Three-step hand hygiene technique with an application time of 30 seconds |
| 3-step hygiene technique, application time of 15 seconds | Experimental | Not described Receives: Procedure: Three-step hand hygiene technique with an application time of 15 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bacterial counts on hands
Change of bacterial counts on hands as determined by the mean logarithmic reduction in bacterial counts after performance of hand hygiene
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start15 Sep 2019
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two different hand hygiene techniques (six steps and three steps) and two different application times for hand rub (30 seconds and 15 seconds)
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Widmer, Prof. Dr. MD, Principal investigator, University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102488
- Sponsor's protocol ID
- 2019-01518; me19Widmer
- Other IDs
- 2019
- Acronym
- SIHAG II
- Status last verified
- Apr 2020
- First submitted
- 24 Sep 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04102488
- Acronym / sponsor ID
- SIHAG II / 2019-01518; me19Widmer
- Conditions
- Hand Hygiene
- Keywords
- reduction of bacterial counts, hand hygiene technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- two different hand hygiene techniques (six steps and three steps) and two different application times for hand rub (30 seconds and 15 seconds)
| Arm | Type | Receives |
|---|---|---|
| 6-step hygiene technique, application time of 30 seconds | Experimental | Procedure: Six-step hand hygiene technique with an application time of 30 seconds |
| 6-step hygiene technique, application time of 15 seconds | Experimental | Procedure: Six-step hand hygiene technique with an application time of 15 seconds |
| 3-step hygiene technique, application time of 30 seconds | Experimental | Procedure: Three-step hand hygiene technique with an application time of 30 seconds |
| 3-step hygiene technique, application time of 15 seconds | Experimental | Procedure: Three-step hand hygiene technique with an application time of 15 seconds |
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Medical students are eligible for participation
- Signed informed consent
Key exclusion criteria (1 listed)
- No signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six-step hand hygiene technique with an application time of 30 secondsSix-step hand hygiene technique with an application time of 30 seconds | Procedure or surgery | 6-step hygiene technique, application time of 30 seconds |
| Six-step hand hygiene technique with an application time of 15 secondsSix-step hand hygiene technique with an application time of 15 seconds | Procedure or surgery | 6-step hygiene technique, application time of 15 seconds |
| Three-step hand hygiene technique with an application time of 30 secondsThree-step hand hygiene technique with an application time of 30 seconds | Procedure or surgery | 3-step hygiene technique, application time of 30 seconds |
| Three-step hand hygiene technique with an application time of 15 secondsThree-step hand hygiene technique with an application time of 15 seconds | Procedure or surgery | 3-step hygiene technique, application time of 15 seconds |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Widmer, Prof. Dr. MD principal investigator
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six-step hand hygiene technique with an application time of 30 seconds, Six-step hand hygiene technique with an application time of 15 seconds and Three-step hand hygiene technique with an application time of 30 seconds in people with Hand Hygiene, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bacterial counts on hands (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.