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Not yet recruiting NCT04187040

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

No phase Interventional Hand Hygiene

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Study intervention: 3-step hand hygiene technique, Control intervention: 6-step hand hygiene technique.
Who it may be relevant to
Registry conditions: Hand Hygiene. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Study 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
  • Procedure Control 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 p

Primary outcome measures

  • Compliance with hand hygiene indications [Time frame: Up to one year]
  • Compliance with the assigned hand hygiene technique [Time frame: Up to one year]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Individuals, who are no HCWs

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04187040 · 2019-01071;me19Tschudinsutter2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗