UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009949 |
|---|---|
| Receipt number | R000011636 |
| Scientific Title | The development of the objective risk assessment indicator for incontinence-associated dermatitis |
| Date of disclosure of the study information | 2013/02/04 |
| Last modified on | 2013/02/04 15:14:26 |
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Basic information
Public title
The development of the objective risk assessment indicator for incontinence-associated dermatitis
Acronym
The development of the objective risk assessment indicator for incontinence-associated dermatitis
Scientific Title
The development of the objective risk assessment indicator for incontinence-associated dermatitis
Scientific Title:Acronym
The development of the objective risk assessment indicator for incontinence-associated dermatitis
Region
| Japan |
Condition
Condition
Elderly patients with incontinence
Classification by specialty
| Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to reveal the physiological and appearance characteristics of skin maceration of older people associated with urine and/or fecal incontinence as a risk indicator of IAD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Physiological data; stratum corneum and dermis hydration levels, transepidermal water loss (TEWL) and skin pH
Skin morphology data
Skin color data; erythema index (EI) and white index (WI)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The patients eligible for enrollment in the study were elderly women who had urinary and/or fecal incontinence and who agreed to participate.
Key exclusion criteria
The exclusion criteria disallowed the participation of patients with a serious medical problem, those who were acutely ill, and those who had skin damage on their buttocks.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshie Ichikawa |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Clinical Nursing
Zip code
Address
5-11-80 Kodatsuno, Kanazawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Clinical Nursing
Zip code
Address
5-11-80 Kodatsuno, Kanazawa
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 02 | Month | 04 | 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
| 2010 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
| 2011 | Year | 04 | Month | 06 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 06 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
complete survey
Management information
Registered date
| 2013 | Year | 02 | Month | 04 | Day |
Last modified on
| 2013 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011636
