UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000039678