UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048838 |
|---|---|
| Receipt number | R000055650 |
| Scientific Title | Development of a prediction model for impairment of skin barrier function due to frictional irritation during hygiene care |
| Date of disclosure of the study information | 2022/09/05 |
| Last modified on | 2023/06/12 13:01:46 |
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Basic information
Public title
Development of a clinical tool to predict impairment of skin barrier function due to frictional irritation during hygiene care
Acronym
Development of a clinical tool to predict impairment of skin barrier function due to frictional irritation during hygiene care
Scientific Title
Development of a prediction model for impairment of skin barrier function due to frictional irritation during hygiene care
Scientific Title:Acronym
Development of a prediction model for impairment of skin barrier function due to frictional irritation during hygiene care
Region
| Japan |
Condition
Condition
Older patients
Classification by specialty
| Dermatology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a clinical tool to predict impairment of skin barrier function due to frictional irritation during hygiene care.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Transepidermal water loss (TEWL)
Key secondary outcomes
Stratum corneum hydration (SCH)
Skin conditions
Medical records
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Wiping three times with 10-20 mmHg of pressure using a cotton towel
Interventions/Control_2
Wiping three times with 20-30 mmHg of pressure using a cotton towel
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients aged >65 years
2) patients are able to communicate daily and sign the informed consent form of the study
Key exclusion criteria
1) patients with excessive sweating 2) patients whose forearms had skin diseases or abnormalities
3) patients with complaints of fever or pain
4) patients with paralysis, peripheral venous catheterization, and hemodialysis shunt in both upper limbs
5) patients who had already received skin care such as bathing, showering, and application of moisturizers or ointments on the day of the data collection
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yano |
| Middle name | |
| Last name | Rika |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812
TEL
0117063323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yano |
| Middle name | |
| Last name | Rika |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812
TEL
0117063323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Health Sciences, Hokkaido University
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812
Tel
0117063323
r-yano@med.hokudai.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
| 2022 | Year | 09 | Month | 05 | 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
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055650
