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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT03588221

Collaborator

(none)

Enrollment

Location

Arms

5.5

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Hygiene	Procedure: four sets of hand hygiene measurements per participant	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized crossover trial, comparing the following 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 secondsRandomized crossover trial, comparing the following 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

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jul 16, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change of bacterial counts on hands pre and post hand hygiene measure [30 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Infectious Diseases and Hospital Epidemiology	Basel		Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Sarah Tschudin Sutter, PD MD, University Hospital Basel, CH-4031 Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT03588221

Other Study ID Numbers:

2018-01049;me18Tschudin-Sutter

First Posted:

Jul 17, 2018

Last Update Posted:

Jan 9, 2019

Last Verified:

Jan 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 9, 2019