UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Chiharu Matsumoto
Organization	Kumamoto University
Division name	Faculty of Life Sciences
Address	4-24-1, Kuhonji Chuo-ku , Kumamoto, Kumamoto, 862-0976, JAPAN
TEL	+81-096-373-5517
Email	matsu-c@kumamoto-u.ac.jp

Public contact
Name of contact person	Chiharu Matsumoto
Organization	Kumamoto University
Division name	Faculty of Life Sciences
Address	4-24-1, Kuhonji Chuo-ku , Kumamoto, Kumamoto, 862-0976, JAPAN
TEL	+81-096-373-5517
Homepage URL
Email	matsu-c@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031818