UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006188 |
|---|---|
| Receipt number | 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 10:22:20 |
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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
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
Sponsor or person
Institute
Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007322
