UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053200 |
|---|---|
| Receipt number | R000060653 |
| Scientific Title | Investigation of the use of quick-drying rubbing hand sanitizers to avoid decreasing their disinfection efficacy. |
| Date of disclosure of the study information | 2023/12/22 |
| Last modified on | 2023/12/22 17:39:44 |
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Basic information
Public title
A study of precautions when using handwashing and quick-drying hand sanitizers together
Acronym
Precautions when using handwashing and quick-drying rubbing hand sanitizers together
Scientific Title
Investigation of the use of quick-drying rubbing hand sanitizers to avoid decreasing their disinfection efficacy.
Scientific Title:Acronym
Prevent loss of disinfectant efficacy of quick-drying hand sanitizers
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify methods for use of quick-drying rubbing hand sanitizers that do not reduce their disinfectant efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of bacteria detected on hand
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
VAN hand wash + quick-drying rubbing hand sanitizer H
Interventions/Control_2
VAN hand wash + quick-drying rubbing hand sanitizer I
Interventions/Control_3
VAN hand wash + quick-drying rubbing hand sanitizer J
Interventions/Control_4
VAN hand wash + quick-drying rubbing hand sanitizer K
Interventions/Control_5
quick-drying rubbing hand sanitizer H
Interventions/Control_6
quick-drying rubbing hand sanitizer I
Interventions/Control_7
quick-drying rubbing hand sanitizer J
Interventions/Control_8
quick-drying rubbing hand sanitizer K
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who are 18 years of age or older at the time of obtaining consent
Persons who are not hypersensitive or allergic to alcohol
Persons who are not hypersensitive or allergic to chlorhexidine gluconate.
Those who do not have wounds or rough (bleeding) fingers.
Persons who have been fully informed of the purpose of participation in this study, and who have given written consent of their own free will based on a thorough understanding of the purpose of participation.
Key exclusion criteria
Persons who are 18 years of age or older at the time of consent
Persons who are not hypersensitive or allergic to alcohol
Persons who are not hypersensitive or allergic to chlorhexidine gluconate.
Those who do not have wounds or rough (bleeding) fingers.
Persons who have been fully informed of the purpose of participation in this study, and who have given written consent of their own free will based on a thorough understanding of the purpose of participation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Shimauchi |
Organization
Miyazaki Prefectural Nursing University
Division name
Chieko Shimauchi
Zip code
880-0929
Address
3-5-1,Manabino,Miyazaki-city,Miyazaki
TEL
0985-59-7713
shima@mpu.ac.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Shimauchi |
Organization
Miyazaki Prefectural Nursing University
Division name
School of Nursing Department of Nursing
Zip code
880-0929
Address
3-5-1,Manabino,Miyazaki-city,Miyazaki
TEL
0985-59-7713
Homepage URL
shima@mpu.ac.jp
Sponsor or person
Institute
Miyazaki Prefectural Nursing University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyazaki Prefectural Nursing University
Address
3-5-1,Manabino,Miyazaki-city,Miyazaki
Tel
0985-59-7713
yuasa3@mcu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060653
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
