UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024609 |
|---|---|
| Receipt number | 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 09:41:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hsanada-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
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 |
