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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009949
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kanazawa University Graduate School of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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