UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050259 |
|---|---|
| Receipt number | R000057237 |
| Scientific Title | Reducing the frequency of handwashing to maintain skin integrity among healthcare workers in the neonatal intensive care unit/growing care unit: A pilot study |
| Date of disclosure of the study information | 2023/02/08 |
| Last modified on | 2024/01/26 10:00:00 |
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Basic information
Public title
Effect of the frequency of handwashing on bacterial colonization and skin physiology on hands
Acronym
Study on the frequency of handwashing
Scientific Title
Reducing the frequency of handwashing to maintain skin integrity among healthcare workers in the neonatal intensive care unit/growing care unit: A pilot study
Scientific Title:Acronym
Study on the frequency of handwashing
Region
| Japan |
Condition
Condition
Hand eczema
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of frequency of handwashing for bacterial colonization and skin physiology on hands
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Residual microbial contamination on the hands of participants
Key secondary outcomes
Skin barrier impairment, assessed via changes in the stratum corneum water content, the trans-epidermal water loss (TEWL), and the skin pH
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Four-time handwashing per one patient.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants were eligible if they were nurses who worked at the NICU/GCU and provided direct patient-care requiring frequent handwashing.
Key exclusion criteria
1. With any skin kind of injury (e.g., cut wound), with the exception of hand eczema, on their hands.
2. Patients who are deemed inappropriate to participate this study, by the principal or study investigators.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masushi |
| Middle name | |
| Last name | Kohta |
Organization
Fujita Health University
Division name
Research Center for Implementation Nursing Science Initiative
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562932000
masushi.kota@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masushi |
| Middle name | |
| Last name | Kohta |
Organization
Fujita Health University
Division name
Research Center for Implementation Nursing Science Initiative
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562932000
Homepage URL
masushi.kota@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
Tel
0562-93-2000
f-irb@fujita-hu.ac.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
| 2023 | Year | 02 | Month | 08 | 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
3
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057237
