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

Hand Hygiene Clinical Trial

— SIMPLIFY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04187040
• Other study ID #: 2019-01071;me19Tschudinsutter2
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Sarah Tschudin Sutter, Prof.Dr.med.
• Phone: +41 61 328 68 10
• Email: sarah.tschudin[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Individuals, who are no HCWs

Related Conditions & MeSH terms

• Hand Hygiene

Intervention

Procedure:
• Study intervention: 3-step hand hygiene technique
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 technique
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to one year
Primary	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.	Up to one year
Secondary	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.	Up to one year
Secondary	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.	Up to one year