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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024609
Receipt No. R000028315
Scientific Title Prevention Effect of Wound Dressings for Pressure Sores in High-Risk Patients
Date of disclosure of the study information 2016/10/28
Last modified on 2018/11/11

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Basic information
Public title Prevention Effect of Wound Dressings for Pressure Sores in High-Risk Patients
Acronym Prevention Effect of Wound Dressings for Pressure Sores in High-Risk Patients
Scientific Title Prevention Effect of Wound Dressings for Pressure Sores in High-Risk Patients
Scientific Title:Acronym Prevention Effect of Wound Dressings for Pressure Sores in High-Risk Patients
Region
Japan

Condition
Condition Pressure Sores
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess the pressure-sores prevention effect of wound dressings attached to the areas of the sacrum bones and the coccyx of the patients with chronic severe diarrhea and/or of the patients with extremely weak skins.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of pressure sores
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Wound dressing is attached to cover
the areas of the sacrum bone and the coccyx.
Interventions/Control_2 No wound dressing is attached to cover
the areas of the sacrum bone and the coccyx.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with high risks of pressure sores who have chronic severe diarrhea and/or extremely weak skins among the patients who will be admitted in the participating medical institutions during the period from April 2016 to March 2017.
Key exclusion criteria who are yet to be 20 years old,
who have skin lesions (including pressure sores) around the sacrum bones and/or the coccyx
Target sample size 600

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, Division of Health Science and Nursing
Zip code
Address 7-3-1 Bunkyo-ku, Hongo, Tokyo 113-0033, JAPAN
TEL 03-5841-3419
Email hsanada-tky@umin.ac.jp

Public contact
Name of contact person
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, Division of Health Science and Nursing
Zip code
Address 7-3-1 Bunkyo-ku, Hongo, Tokyo 113-0033, JAPAN
TEL 03-5841-3419
Homepage URL
Email hsanada-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Japanese Society of Wound Ostomy Continence Management
Organization
Division
Category of Funding Organization Other
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 福西会病院(福岡県)
日本医科大学付属病院(東京都)
東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 28 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
2016 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 22 Day
Last follow-up date
2018 Year 04 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 28 Day
Last modified on
2018 Year 11 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028315

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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