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


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 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


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

Value
https://center6.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