UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention Effect of Wound Dressings for Pressure Sores in High-Risk Patients
Title of the study (Brief title)	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	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
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	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
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028315