UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029680 |
|---|---|
| Receipt number | R000033914 |
| Scientific Title | Effects of robotic mattress on pressure ulcer healing, comfort level among pressure ulcer patients, and nursing work load: a randomized controlled trial |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2017/10/23 23:45:05 |
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Basic information
Public title
Effects of robotic mattress on pressure ulcer healing, comfort level among pressure ulcer patients, and nursing work load: a randomized controlled trial
Acronym
Effects of robotic mattress on pressure ulcer healing, comfort level among pressure ulcer patients, and nursing work load: a randomized controlled trial
Scientific Title
Effects of robotic mattress on pressure ulcer healing, comfort level among pressure ulcer patients, and nursing work load: a randomized controlled trial
Scientific Title:Acronym
Effects of robotic mattress on pressure ulcer healing, comfort level among pressure ulcer patients, and nursing work load: a randomized controlled trial
Region
| Japan |
Condition
Condition
pressure ulcers
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether a robotic mattress is more effective on pressure ulcer healing, comfort level among pressure ulcer patients and nursing work load compared with a standard mattress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wound healing rate within 3 weeks
Key secondary outcomes
patient comfort level, nursing work load
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
Use of a robotic mattress
Interventions/Control_2
Use of a standard 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
Patients with pressure ulcers in their sacral, coccyx, ischial tuberosity, greater trochanter, or heel
Key exclusion criteria
Medical device related pressure ulcers,
Patients who are not allowed to participate by the medical staff,
Patients with a risk of falling,
Patients who are not eligible for the use of air mattress,
Patients without consent
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gojiro Nakagami |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
Address
Faculty of Medicine Bldg. 5-307, 7-3-1, Hongo, Bunkyo-ku, Tokyo,Japan
TEL
03-5841-3424
gojiron-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Kitamura |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
Address
Faculty of Medicine Bldg. 5-301, 7-3-1, Hongo, Bunkyo-ku, Tokyo,Japan
TEL
03-5841-3451
Homepage URL
ktmr-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | 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
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2017 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033914
