Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000462886
Ethics application status
Approved
Date submitted
4/02/2021
Date registered
20/04/2021
Date last updated
20/04/2021
Date data sharing statement initially provided
20/04/2021
Date results information initially provided
20/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of different hand sanitizers on the microbes on fingers
Scientific title
Effect of different hand sanitizers on the number of microbes on fingers of healthy volunteers
Secondary ID [1] 303348 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand contamination 320610 0
Condition category
Condition code
Skin 318462 318462 0 0
Other skin conditions
Infection 318805 318805 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will use different hand sanitizers and have their fingers cultured after each use.
Participants will use each hand sanitizer in a random order for 30 seconds
There is a washout period of a minimum of 3 days between use of the different hand sanitizers
Hand sanitizers will contain with Decanoic acid, ethanol or a quaternary ammonium compound as the active ingredients. The hand sanitizers are "Doxall" manufactured by Wintermute Biomedical (1.5% decanoic acid as active ingredient), "Dettol" manufactured by Reckitt Benckiser (70% ethanol as active ingredient) and "Zoono" manufactured by Zoono Group (0.6% quaternary ammonium compounds as active ingredient)
Intervention code [1] 319660 0
Treatment: Devices
Comparator / control treatment
The microbiology of fingers before use of hand sanitizers is control
Control group
Active

Outcomes
Primary outcome [1] 326426 0
Composite primary outcome of numbers of bacteria and fungi on fingers at different time points (10 or 20 minutes and 4 hours ) after use of hand sanitizers.. Microbe numbers counted after growth on agar plates.
Timepoint [1] 326426 0
baseline (prior to use of hand sanitizers), 10 and 20 minutes and 4 hours after use
Secondary outcome [1] 392579 0
Nil
Timepoint [1] 392579 0
Nil

Eligibility
Key inclusion criteria
Willing to adhere to study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infections on hands; known allergy to hand sanitizer ingredients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/02/2021
Date of last participant enrolment
Anticipated
Actual
26/03/2021
Date of last data collection
Anticipated
Actual
27/03/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32950 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 307764 0
Commercial sector/Industry
Name [1] 307764 0
Wintermute Biomedical
Country [1] 307764 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSW Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 308467 0
None
Name [1] 308467 0
Address [1] 308467 0
Country [1] 308467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307787 0
University of New South Wales
Ethics committee address [1] 307787 0
UNSW Sydney, NSW 2052
Ethics committee country [1] 307787 0
Australia
Date submitted for ethics approval [1] 307787 0
Approval date [1] 307787 0
05/10/2020
Ethics approval number [1] 307787 0

Summary
Brief summary
The primary purpose is to evaluate how long a single hand disinfection lasts.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108490 0
Prof Mark Willcox
Address 108490 0
UNSW Sydney, NSW 2052
Country 108490 0
Australia
Phone 108490 0
+61 290655394
Fax 108490 0
Email 108490 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 108491 0
Prof Mark Willcox
Address 108491 0
UNSW Sydney, NSW 2052
Country 108491 0
Australia
Phone 108491 0
+61 290655394
Fax 108491 0
Email 108491 0
m.willcox@unsw.edu.au
Contact person for scientific queries
Name 108492 0
Prof Mark Willcox
Address 108492 0
UNSW Sydney, NSW 2052
Country 108492 0
Australia
Phone 108492 0
+61 290655394
Fax 108492 0
Email 108492 0
m.willcox@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.