UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053450 |
|---|---|
| Receipt number | R000061000 |
| Scientific Title | A randomized crossover pilot study evaluating facial bacterial colonization and skin physiology during single or repeated use of face mask in nurses |
| Date of disclosure of the study information | 2024/01/27 |
| Last modified on | 2024/01/26 11:27:39 |
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Basic information
Public title
Effects of replacing the mask on facial bacterial growth and skin physiology in nurses
Acronym
Effects of replacing the mask on facial bacterial growth and skin physiology in nurses
Scientific Title
A randomized crossover pilot study evaluating facial bacterial colonization and skin physiology during single or repeated use of face mask in nurses
Scientific Title:Acronym
A randomized crossover pilot study evaluating facial bacterial colonization and skin physiology during single or repeated use of face mask in nurses
Region
| Japan |
Condition
Condition
contact dermatitis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of replacing the mask during daily work of nurses on facial bacterial growth and skin physiology.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of bacterial growth on face
Key secondary outcomes
Detection rate of specific bacteria
Skin physiology
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Replacing the mask during daily work
Interventions/Control_2
Not replacing the mask during daily work
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses at Fujita Health University Hospital Disaster Trauma Center in 2023 and 2024
Key exclusion criteria
None
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Sugama |
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
junko.sugama@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
Self funding
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
0562932000
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
藤田医科大学病院（愛知県）
Fujita Health University Hospital (Aichi prefecture)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061000
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
