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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035568
Receipt No. R000037035
Scientific Title Evaluation of pressure ulcer prevention and QOL for using dual-fit-air-cell-mattresses
Date of disclosure of the study information 2019/01/16
Last modified on 2019/01/16

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Basic information
Public title Evaluation of pressure ulcer prevention and QOL for using dual-fit-air-cell-mattresses
Acronym Evaluation of pressure ulcer prevention and comfort for using air-cell-mattresses
Scientific Title Evaluation of pressure ulcer prevention and QOL for using dual-fit-air-cell-mattresses
Scientific Title:Acronym Evaluation of pressure ulcer prevention and comfort for using air-cell-mattresses
Region
Japan

Condition
Condition High risk of Pressure ulcer
Selection of air-cell-mattresses
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate pressure ulcer prevention and comfort for using air-cell-mattresses
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quality of life : Comfort
Key secondary outcomes Development of pressure ulcer

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 dual-fit-air-cell mattress
Interventions/Control_2 two-layer-air-cell mattress
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 Pressure ulcer high risk
Key exclusion criteria Presence of Pressure ulcer
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Marutani
Organization Kanazawa University Hospital
Division name Department of Nursing
Zip code
Address 13-1, Takaramati, Kanazawa-shi
TEL 076-265-2000
Email amaru-tkf@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Marutani
Organization Kanazawa University Hospital
Division name Department of Nursing
Zip code
Address 13-1, Takaramati, Kanazawa-shi
TEL 076-265-2000
Homepage URL
Email amaru-tkf@umin.ac.jp

Sponsor
Institute Kanazawa University
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
2019 Year 01 Month 16 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
2007 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 16 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037035

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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