NCT03588221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

July 3, 2018

Last Update Submit

January 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Six-step hand hygiene technique with application time of 30

OTHER
Procedure: four sets of hand hygiene measurements per participant

Six-step hand hygiene technique with application time of 15

OTHER
Procedure: four sets of hand hygiene measurements per participant

Three-step hand hygiene technique with application time of 3

OTHER
Procedure: four sets of hand hygiene measurements per participant

Three-step hand hygiene technique with application time of 1

OTHER
Procedure: four sets of hand hygiene measurements per participant

Interventions

1. Six-step hand hygiene technique with an application time of 30 seconds 2. Six-step hand hygiene technique with an application time of 15 seconds 3. Three-step hand hygiene technique with an application time of 30 seconds 4. Three-step hand hygiene technique with an application time of 15 seconds

Six-step hand hygiene technique with application time of 15Six-step hand hygiene technique with application time of 30Three-step hand hygiene technique with application time of 1Three-step hand hygiene technique with application time of 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants (≥18 years)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Infectious Diseases and Hospital Epidemiology

Basel, 4031, Switzerland

Location

Study Officials

  • Sarah Tschudin Sutter, PD MD

    University Hospital Basel, CH-4031 Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: Randomized crossover trial, comparing the following four sets of hand hygiene measurements per participant: 1. Six-step hand hygiene technique with an application time of 30 seconds 2. Six-step hand hygiene technique with an application time of 15 seconds 3. Three-step hand hygiene technique with an application time of 30 seconds 4. Three-step hand hygiene technique with an application time of 15 seconds
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 17, 2018

Study Start

July 16, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations