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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04187040
Other study ID # 2019-01071;me19Tschudinsutter2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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