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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034809
Receipt No. R000039678
Scientific Title Ultra-pure soft water prevent and improve hand dermatitis among nurses
Date of disclosure of the study information 2018/12/18
Last modified on 2019/05/10

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Basic information
Public title Ultra-pure soft water prevent and improve hand dermatitis among nurses
Acronym Effectiveness of ultra-pure soft water
Scientific Title Ultra-pure soft water prevent and improve hand dermatitis among nurses
Scientific Title:Acronym Effectiveness of ultra-pure soft water
Region
Japan

Condition
Condition nosocomial infection
Classification by specialty
Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate hand dermatitis protective effects of ultra-pure soft water among nurses in a neonatal intensive care unit
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison between the before and after exposure to ultra-pure soft water in hand dermatitis, transepidermal water loss, and water content of stratum corneum
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Water to wash hands
First Intervention(4 weeks): ultra-pure soft water
Washout (2 weeks): tap water
Second Intervention(4 weeks): tap water
Interventions/Control_2 Water to wash hands
First Intervention(4 weeks): tap water
Washout (2 weeks): tap water
Second Intervention(4 weeks): ultra-pure soft water
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Nurses working in the neonatal intensive care unit of Tokyo Metropolitan Children's Medical Center
Nurses with full consent from the person's free will with sufficient understanding
Key exclusion criteria Nurses who did not obtain consent to participate in the research
Nurses who research managers judged inappropriate as research subjects
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kaoru
Middle name
Last name Okazaki
Organization Tokyo Metropolitan Children's Medical Center
Division name Neonatology
Zip code 183-8561
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo 183-8561, Japan
TEL 042-300-5111
Email kaoru_okazaki@tmhp.jp

Public contact
Name of contact person
1st name Kaoru
Middle name
Last name Okazaki
Organization Tokyo Metropolitan Children's Medical Center
Division name Neonatology
Zip code 183-8561
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo 183-8561, Japan
TEL 042-300-5111
Homepage URL
Email kaoru_okazaki@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor MIURA Co., Ltd.
Name of secondary funder(s) no

IRB Contact (For public release)
Organization Tokyo Metropolitan Children's Medical Center
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo 183-8561, Japan
Tel 042-300-5111
Email sn_chiken-jimu@tmhp.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
2018 Year 12 Month 18 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 Completed
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
2018 Year 12 Month 19 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039678

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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