UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027764 |
|---|---|
| Receipt number | R000031818 |
| Scientific Title | Comparison of effect on skin microbial flora, skin moisturisation and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2018/06/16 15:43:37 |
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Basic information
Public title
Comparison of effect on skin microbial flora, skin moisturisation and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels
Acronym
The effect on skin and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels
Scientific Title
Comparison of effect on skin microbial flora, skin moisturisation and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels
Scientific Title:Acronym
The effect on skin and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect on skin and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of skin bacteria, the water content in epidermal stratum corneum and relaxation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The partial bed bath using cotton towels
Check of six times for a day (before practice, just after, 10 minutes later, 20 minutes later, 30 minutes later and 60 minutes later practice)
Interventions/Control_2
The partial bed bath using disposable wet towels
Check of six times for a day (before practice, just after, 10 minutes later, 20 minutes later, 30 minutes later and 60 minutes later practice)
Interventions/Control_3
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females
Key exclusion criteria
-Subjects who have been suffered from a critical disease
-Subjects with allergy
-Subjects who are in poor physical condition
-Subjects who have an abnormality of measurement skin site
-Subjects undergoing trauma in the measurement site
-Subjects who are influenced by the adhesive
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiharu Matsumoto |
Organization
Kumamoto University
Division name
Faculty of Life Sciences
Zip code
Address
4-24-1, Kuhonji Chuo-ku , Kumamoto, Kumamoto, 862-0976, JAPAN
TEL
+81-096-373-5517
matsu-c@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Matsumoto |
Organization
Kumamoto University
Division name
Faculty of Life Sciences
Zip code
Address
4-24-1, Kuhonji Chuo-ku , Kumamoto, Kumamoto, 862-0976, JAPAN
TEL
+81-096-373-5517
Homepage URL
matsu-c@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
NITI-ON
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NITI-ON
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 15 | 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
Both disposable bath and towel bath significantly decreased resident skin bacteria. Disposable bath also significantly reduced Staphylococcus aureus and effectively maintained the hydration level of the stratum corneum. Furthermore, disposable bath was as effective as towel bath at contributing to participants' relaxation levels.
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 15 | Day |
Last modified on
| 2018 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031818
