UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034809 |
|---|---|
| Receipt number | 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 12:31:54 |
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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
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
kaoru_okazaki@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
