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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006188
Receipt No. R000007322
Scientific Title Effectiveness of a new absorbent pad on incontinence-associated dermatitis in older adult women
Date of disclosure of the study information 2011/08/19
Last modified on 2011/08/18

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Basic information
Public title Effectiveness of a new absorbent pad on incontinence-associated dermatitis in older adult women
Acronym Effectiveness of a new absorbent pad on incontinence-associated dermatitis in older adult women
Scientific Title Effectiveness of a new absorbent pad on incontinence-associated dermatitis in older adult women
Scientific Title:Acronym Effectiveness of a new absorbent pad on incontinence-associated dermatitis in older adult women
Region
Japan

Condition
Condition disuse syndrome
Classification by specialty
Medicine in general Geriatrics Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to examine the effectiveness of the new absorbent pad against incontinence associated dermatitis (IAD)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes healing rate of IAD
The severity score assessed using the IAD Skin Condition Assessment Tool
Key secondary outcomes skin pH and skin moisture

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Using incontinence care pad with frontal absorbent material in daytime from August 17, 2007 to September 2, 2007
Interventions/Control_2 Using standard absorbent pad from August 17, 2007 to September 2, 2007
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 1)adult women of 65 years and older
2)diagnosed with IAD
3) full time user of diapers (including absorbent pads) due to urinary incontinence. No criteria were specified regarding the type of incontinence
Key exclusion criteria 1) diagnosed with a skin disorder other than IAD in the buttocks area, such as pressure ulcers, that required special medical care other than the selection of absorbent pad
2) suffering from diarrhea
3) poor general medical status
4) scheduled to be discharged within a week
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Sanada
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Gerontological Nursing/Wound Care Management
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Gerontological Nursing/Wound Care Management
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo
Institute
Department

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
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
2011 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Using the new absorbent pad for the older adults with urine incontinence might be more effective to IAD healing than usual absorbent pad. This result was presented at the 21st annual meeting of Japanese society of geriatrics urology in 2008.
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
2007 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2007 Year 09 Month 01 Day
Date of closure to data entry
2007 Year 09 Month 01 Day
Date trial data considered complete
2008 Year 04 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 18 Day
Last modified on
2011 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007322

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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