Skip to content

SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study)

SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene - an International Multicenter Cluster Randomized Trial (SIMPLIFY Study)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04187040
Acronym
SIMPLIFY
Enrollment
40
Registered
2019-12-05
Start date
2026-12-01
Completion date
2026-12-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Hygiene

Keywords

WHO-guideline on hand hygiene in healthcare, 3-step hand hygiene technique, 6-step hand hygiene technique

Brief 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. 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.

Interventions

PROCEDUREStudy intervention: 3-step hand hygiene technique

3-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

PROCEDUREControl intervention: 6-step hand hygiene technique

6-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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe

Exclusion criteria

Individuals, who are no HCWs

Design outcomes

Primary

MeasureTime frameDescription
Compliance with hand hygiene indicationsUp to one yearCompliance 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 techniqueUp to one yearCompliance 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.

Secondary

MeasureTime frameDescription
Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertipsUp to one yearCompliance 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.
Duration of the hand hygiene actionUp to one yearDuration of the hand hygiene action, the time spent for the application of hand rub will be measured and compared between the two assignments.

Contacts

CONTACTSarah Tschudin Sutter, Prof.Dr.med.
sarah.tschudin@usb.ch+41 61 328 68 10
PRINCIPAL_INVESTIGATORSarah Tschudin Sutter, Prof.Dr.med.

University Hospital, Basel, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026