UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of pressure ulcer prevention and QOL for using dual-fit-air-cell-mattresses
Title of the study (Brief title)	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	Akiko Marutani
Organization	Kanazawa University Hospital
Division name	Department of Nursing
Address	13-1, Takaramati, Kanazawa-shi
TEL	076-265-2000
Email	amaru-tkf@umin.ac.jp

Public contact
Name of contact person	Akiko Marutani
Organization	Kanazawa University Hospital
Division name	Department of Nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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