SIHAG II: Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene: Three Steps and 15 Seconds

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04102488

Collaborator

(none)

Enrollment

Location

Arms

5.2

Actual Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.

Condition or Disease	Intervention/Treatment	Phase
Hand Hygiene	Procedure: Six-step hand hygiene technique with an application time of 30 seconds Procedure: Six-step hand hygiene technique with an application time of 15 seconds Procedure: Three-step hand hygiene technique with an application time of 30 seconds Procedure: Three-step hand hygiene technique with an application time of 15 seconds	N/A

Detailed Description

The WHO guideline recommends 30 seconds for application of hand rub, however, mean bacterial reduction after 15 seconds of hand rubbing has been recently shown to be non-inferior and shortening application time to 15 seconds has been suggested to improve the frequency of hand hygiene actions in a neonatal care unit. This study is to investigate that non-inferiority in terms of reduction of bacterial counts will be retained when combining the simpler three-step technique for the use of hand rub with a shorter application time of 15 seconds.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two different hand hygiene techniques (six steps and three steps) and two different application times for hand rub (30 seconds and 15 seconds)two different hand hygiene techniques (six steps and three steps) and two different application times for hand rub (30 seconds and 15 seconds)

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Simplifying Hand Hygiene Technique: Six Steps and 30 Seconds Versus Six Steps and 15 Seconds Versus Three Steps and 30 Seconds Versus Three Steps and 15 Seconds

Actual Study Start Date :

Sep 15, 2019

Actual Primary Completion Date :

Feb 21, 2020

Actual Study Completion Date :

Feb 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 6-step hygiene technique, application time of 30 seconds	Procedure: Six-step hand hygiene technique with an application time of 30 seconds Six-step hand hygiene technique with an application time of 30 seconds
Experimental: 6-step hygiene technique, application time of 15 seconds	Procedure: Six-step hand hygiene technique with an application time of 15 seconds Six-step hand hygiene technique with an application time of 15 seconds
Experimental: 3-step hygiene technique, application time of 30 seconds	Procedure: Three-step hand hygiene technique with an application time of 30 seconds Three-step hand hygiene technique with an application time of 30 seconds
Experimental: 3-step hygiene technique, application time of 15 seconds	Procedure: Three-step hand hygiene technique with an application time of 15 seconds Three-step hand hygiene technique with an application time of 15 seconds

Outcome Measures

Primary Outcome Measures

Change of bacterial counts on hands [30 minutes]
Change of bacterial counts on hands as determined by the mean logarithmic reduction in bacterial counts after performance of hand hygiene

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 31 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Medical students are eligible for participation
Signed informed consent

Exclusion Criteria:

No signed 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: Andreas Widmer, Prof. Dr. MD, University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT04102488

Other Study ID Numbers:

2019-01518; me19Widmer

First Posted:

Sep 25, 2019

Last Update Posted:

Apr 8, 2020

Last Verified:

Apr 1, 2020

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

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

Keywords provided by University Hospital, Basel, Switzerland

reduction of bacterial counts

hand hygiene technique

Study Results

No Results Posted as of Apr 8, 2020