Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene (SIHAG)

Simplifying the WHO Protocol for Hand Hygiene: Three Steps and 15 Seconds - a Randomized Cross-over Trial

Non-inferiority in terms of reduction of bacterial counts will be investigated when combining the simpler three-step hand hygiene technique for the use of hand rub with a shorter application time of 15 seconds compared to the to the three steps technique with an application time of 30 seconds and the technique consisting in six steps.

Study Overview

• Status: Completed
• Conditions: Hand Hygiene
• Intervention / Treatment: Procedure: four sets of hand hygiene measurements per participant

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Division of Infectious Diseases and Hospital Epidemiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult participants (≥18 years)

Exclusion Criteria:

• skin disorders as determined by a dermatologist
• inability to follow procedures
• insufficient knowledge of the project language
• inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Six-step hand hygiene technique with application time of 30	Procedure: four sets of hand hygiene measurements per participant; Six-step hand hygiene technique with an application time of 30 seconds; Six-step hand hygiene technique with an application time of 15 seconds; Three-step hand hygiene technique with an application time of 30 seconds; Three-step hand hygiene technique with an application time of 15 seconds
Other: Six-step hand hygiene technique with application time of 15	Procedure: four sets of hand hygiene measurements per participant; Six-step hand hygiene technique with an application time of 30 seconds; Six-step hand hygiene technique with an application time of 15 seconds; Three-step hand hygiene technique with an application time of 30 seconds; Three-step hand hygiene technique with an application time of 15 seconds
Other: Three-step hand hygiene technique with application time of 3	Procedure: four sets of hand hygiene measurements per participant; Six-step hand hygiene technique with an application time of 30 seconds; Six-step hand hygiene technique with an application time of 15 seconds; Three-step hand hygiene technique with an application time of 30 seconds; Three-step hand hygiene technique with an application time of 15 seconds
Other: Three-step hand hygiene technique with application time of 1	Procedure: four sets of hand hygiene measurements per participant; Six-step hand hygiene technique with an application time of 30 seconds; Six-step hand hygiene technique with an application time of 15 seconds; Three-step hand hygiene technique with an application time of 30 seconds; Three-step hand hygiene technique with an application time of 15 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of bacterial counts on hands pre and post hand hygiene measure	The log counts of bacteria detected on the dominant hand will be averaged separately for pre- and post values. Differences between pre- and post values, as well as in the mean logarithmic reduction in bacterial counts will be compared	30 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Sarah Tschudin Sutter, PD MD, University Hospital Basel, CH-4031 Basel

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-01049;me18Tschudin-Sutter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No