Hand HygieneSIMPLIFYNCT04187040
SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study)
A study testing Study intervention: 3-step hand hygiene technique in people with Hand Hygiene, run by University Hospital, Basel, Switzerland.
Trial summary
Hand hygiene is one of the most important measures to prevent healthcare associated infections. A hand hygiene technique consisting of three steps may be superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- Study intervention: 3-step hand hygiene technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe
Who cannot join
- Individuals, who are no HCWs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene - an International Multicenter Cluster Randomized Trial (SIMPLIFY Study)
Hand hygiene is one of the most important measures to prevent healthcare associated infections. A hand hygiene technique consisting of three steps may be superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique. Therefore, the aim of this study is to compare compliance with hand hygiene indications and technique between a 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.
Read the detailed description
Hand hygiene is one of the most important measures to prevent transmission of pathogens between healthcare workers and patients, and ultimately, healthcare-associated infections. However, compliance with both hand hygiene indications and technique (outlining the steps for applying hand rub to ensure coverage of all surfaces of the hands) remains insufficient at most institutions worldwide. It was previously demonstrated that a hand hygiene technique consisting of three steps is superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique in a single center study. Furthermore, the 3-step technique was non-inferior regarding microbiological efficacy in two experimental studies and during daily clinical practice. To further investigate the external validity and generalizability of these findings to different settings, this study compares both compliance with hand hygiene indications and technique between the 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.
- Conditions
- Hand Hygiene
- Being tested
- Study intervention: 3-step hand hygiene technique, Control intervention: 6-step hand hygiene technique
- Keywords
- WHO-guideline on hand hygiene in healthcare, 3-step hand hygiene technique, 6-step hand hygiene technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study intervention: 3-step hand hygiene techniqueProcedure or surgery
3-step hand hygiene technique:
- Covering all surfaces of the hands (based on own judgement)
- Rotational rubbing of fingertips in the palm of the alternate hand
- Rotational rubbing of both thumbs
Control intervention: 6-step hand hygiene techniqueProcedure or surgery
6-step hand hygiene technique (according to the WHO Guidelines on Hand Hygiene in Health Care, First Global Patient Safety Challenge):
- Rubbing hands palm to palm
- Palm to palm with fingers interlaced
- Right palm over left dorsum with interlaced fingers and vice versa
- Back of fingers to opposing palms with fingers interlocked
- Rotational rubbing of left thumb clasped in right palm and vice versa
- Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa
| Study group | Role | What they receive |
|---|---|---|
| 3-step hand hygiene technique | Active comparator | Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 3-step hand hygiene technique. Receives: Procedure: Study intervention: 3-step hand hygiene technique |
| 6-step hand hygiene technique | Active comparator | Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 6-step hand hygiene technique. Receives: Procedure: Control intervention: 6-step hand hygiene technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with hand hygiene indications
Compliance with the five hand hygiene indications defined by the WHO:
- before touching a patient
- before clean/aseptic procedures
- after body fluid exposure risk
- after touching a patient
- after touching patient surroundings
Measured: Up to one year
Compliance with the assigned hand hygiene technique
Compliance with the assigned technique, defined as performance of the proposed three steps in the intervention group and of all six steps in the control group.
Measured: Up to one year
Secondary outcomes (2)
Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips
Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips, which are part of both the 3-step and the 6-step technique for applying hand rub.
Measured: Up to one year
Duration of the hand hygiene action
Duration of the hand hygiene action, the time spent for the application of hand rub will be measured and compared between the two assignments.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participating wards will be randomly assigned with a 1:1 allocation to either the intervention (3-step hand hygiene technique) or the control group (6-step hand hygiene technique). Randomization will be stratified by participating institution for balanced allocation. Within each stratum, block randomization will be applied to assign wards to the two study groups. Blocking will be used to ensure close balance of the number of wards assigned to each group at any time during the study. Stratified randomization will be performed to ensure balance of the two groups within each institution.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Tschudin Sutter, Prof.Dr.med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187040
- Sponsor's protocol ID
- 2019-01071;me19Tschudinsutter2
- Other IDs
- 2019
- Acronym
- SIMPLIFY
- Status last verified
- Jun 2026
- First submitted
- 12 Nov 2019
- Last updated
- 8 Jun 2026
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene - an International Multicenter Cluster Randomized Trial (SIMPLIFY Study)
- ClinicalTrials.gov ID
- NCT04187040
- Acronym / sponsor ID
- SIMPLIFY / 2019-01071;me19Tschudinsutter2
- Conditions
- Hand Hygiene
- Keywords
- WHO-guideline on hand hygiene in healthcare, 3-step hand hygiene technique, 6-step hand hygiene technique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Dec 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.
Hand hygiene is one of the most important measures to prevent healthcare associated infections. A hand hygiene technique consisting of three steps may be superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique. Therefore, the aim of this study is to compare compliance with hand hygiene indications and technique between a 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.
Detailed description
Hand hygiene is one of the most important measures to prevent transmission of pathogens between healthcare workers and patients, and ultimately, healthcare-associated infections. However, compliance with both hand hygiene indications and technique (outlining the steps for applying hand rub to ensure coverage of all surfaces of the hands) remains insufficient at most institutions worldwide. It was previously demonstrated that a hand hygiene technique consisting of three steps is superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique in a single center study. Furthermore, the 3-step technique was non-inferior regarding microbiological efficacy in two experimental studies and during daily clinical practice. To further investigate the external validity and generalizability of these findings to different settings, this study compares both compliance with hand hygiene indications and technique between the 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participating wards will be randomly assigned with a 1:1 allocation to either the intervention (3-step hand hygiene technique) or the control group (6-step hand hygiene technique). Randomization will be stratified by participating institution for balanced allocation. Within each stratum, block randomization will be applied to assign wards to the two study groups. Blocking will be used to ensure close balance of the number of wards assigned to each group at any time during the study. Stratified randomization will be performed to ensure balance of the two groups within each institution.
| Arm | Type | Receives |
|---|---|---|
| 3-step hand hygiene technique | Active comparator | Procedure: Study intervention: 3-step hand hygiene techniqueWards assigned to this study arm will receive instructions, educational materials and tutorials about the 3-step hand hygiene technique. |
| 6-step hand hygiene technique | Active comparator | Procedure: Control intervention: 6-step hand hygiene techniqueWards assigned to this study arm will receive instructions, educational materials and tutorials about the 6-step hand hygiene technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe
Key exclusion criteria (1 listed)
- Individuals, who are no HCWs
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 |
|---|---|---|
| Study intervention: 3-step hand hygiene technique3-step hand hygiene technique: 1. Covering all surfaces of the hands (based on own judgement) 2. Rotational rubbing of fingertips in the palm of the alternate hand 3. Rotational rubbing of both thumbs | Procedure or surgery | 3-step hand hygiene technique |
| Control intervention: 6-step hand hygiene technique6-step hand hygiene technique (according to the WHO Guidelines on Hand Hygiene in Health Care, First Global Patient Safety Challenge): 1. Rubbing hands palm to palm 2. Palm to palm with fingers interlaced 3. Right palm over left dorsum with interlaced fingers and vice versa 4. Back of fingers to opposing palms with fingers interlocked 5. Rotational rubbing of left thumb clasped in right palm and vice versa 6. Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa | Procedure or surgery | 6-step hand hygiene technique |
Primary outcome
Compliance with hand hygiene indications
Time frame: Up to one year
Compliance with the five hand hygiene indications defined by the WHO: * before touching a patient * before clean/aseptic procedures * after body fluid exposure risk * after touching a patient * after touching patient surroundings
Compliance with the assigned hand hygiene technique
Time frame: Up to one year
Compliance with the assigned technique, defined as performance of the proposed three steps in the intervention group and of all six steps in the control group.
2 secondary outcomes
Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips
Time frame: Up to one year
Duration of the hand hygiene action
Time frame: Up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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.
Sarah Tschudin Sutter, Prof.Dr.med. principal investigator
University Hospital, Basel, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing Study intervention: 3-step hand hygiene technique in people with Hand Hygiene, run by University Hospital, Basel, 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 1 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Tschudin Sutter, Prof.Dr.med. (+41 61 328 68 10, sarah.tschudin@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with hand hygiene indications (time frame: Up to one year). The study lists 2 primary outcomes in all. 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 Jun 2026.