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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045651
Receipt No. R000052115
Scientific Title Effects of differences in wiping pressure using disposable towels on skin barrier function, skin cleanliness, and subjective evaluations: A single-blind randomized crossover trial
Date of disclosure of the study information 2021/10/04
Last modified on 2021/10/04

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Basic information
Public title Effects of differences in wiping pressure using disposable towels on skin barrier function, skin cleanliness, and subjective
evaluations
Acronym Effects of differences in wiping pressure using disposable towels on skin barrier function, skin cleanliness, and subjective
evaluations
Scientific Title Effects of differences in wiping pressure using disposable towels on skin barrier function, skin cleanliness, and subjective
evaluations: A single-blind randomized crossover trial
Scientific Title:Acronym Effects of differences in wiping pressure using disposable towels on skin barrier function, skin cleanliness, and subjective
evaluations: A single-blind randomized crossover trial
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of differences in
wiping pressure using disposable towels on
skin barrier function, skin cleanliness, and subjective evaluations.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Transepidermal water loss (TEWL)
Key secondary outcomes Stratum corneum hydration (SCH)
Subjective evaluation
Adenosine triphosphate (ATP)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Weak WIPE
Interventions/Control_2 Strong WIPE
Interventions/Control_3 Ordinary WIPE
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adults aged >20 years
Key exclusion criteria Participants whose forearms had skin
diseases or skin abnormalities such as
severe redness, swelling, hematoma, erosion, and edema

Participants with paralysis in both upper limbs
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yano
Middle name
Last name Rika
Organization Faculty of Health Sciences, Hokkaido
University
Division name Department of Fundamental Nursing
Zip code 060-0812
Address Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-3323
Email r-yano@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yano
Middle name
Last name Rika
Organization Faculty of Health Sciences, Hokkaido University
Division name Department of Fundamental Nursing
Zip code 060-0812
Address Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-3323
Homepage URL
Email r-yano@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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 Faculty of Health Sciences, Hokkaido University
Address Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812 Japan
Tel 011-706-3316
Email shomu@hs.hokudai.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
2021 Year 10 Month 04 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
2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 10 Day
Last follow-up date
2022 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
2021 Year 10 Month 04 Day
Last modified on
2021 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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