UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058312 |
|---|---|
| Receipt number | R000066554 |
| Scientific Title | The effectiveness of multi-layered silicone foam dressings in preventing pressure injury in patients who have been bedridden for a long time was examined using subepidermal moisture measurements |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/27 06:31:57 |
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Basic information
Public title
The effectiveness of multi-layered silicone foam dressings in preventing pressure injury in patients who have been bedridden for a long time was examined using subepidermal moisture measurements
Acronym
Examination of the effectiveness of dressing materials in preventing pressure injury using subepidermal moisture measurements
Scientific Title
The effectiveness of multi-layered silicone foam dressings in preventing pressure injury in patients who have been bedridden for a long time was examined using subepidermal moisture measurements
Scientific Title:Acronym
Examination of the effectiveness of dressing materials in preventing pressure injury using subepidermal moisture measurements
Region
| Japan |
Condition
Condition
long-term bedridden patients
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use SEM measurement to clarify the effect of preventive dressings on patients who have been bedridden for a long time, and to verify the relationship between the application of preventive dressings and the occurrence of pressure injury .
If this study clarifies the effect of preventive dressings on patients who have been bedridden for a long time, it will lead to the expansion of methods for preventing pressure injury in chronic care wards where many long-term bedridden patients are hospitalized. Furthermore, there has been little research in Japan on SEM measurement and pressure injury , and this is the first study to use an SEM Scanner, particularly on Japanese subjects. If this study helps to build evidence regarding SEM measurement and early detection of pressure injury in Japanese patients, SEM measurement may become the standard tool for detecting pressure injury in Japan, and may become an earlier and more accurate method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient data will be collected from the medical records of the study subjects, including their age, sex, disease, date of hospitalization, level of independence in daily life for disabled elderly people, and weight. In addition, BMI will be calculated from the medical record information, and nutritional status will be evaluated using the MNA-SF35), a simplified version of a nutritional assessment tool for the elderly. Furthermore, together with the nurse in charge of the study subjects, data will be collected on the presence or absence of joint contractures, evaluation using the Braden Scale36), a pressure injury risk assessment scale, and the presence or absence of IAD (incontinence-associated dermatitis), and palpation will be used to confirm whether or not there is a bony prominence in the sacrum of the study subjects.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
No dressing
Interventions/Control_2
The "spine" version of Mepilex Border Protect (Molnlycke Healthcare, Tokyo), a multi-layered silicone foam dressing, is applied to the sacrum, and the "heel" version is applied to both heels.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Any age.
2) Any gender.
3) Disabled elderly patients with a level of independence in daily living of B or C.
4) Patients with no skin damage at the measurement sites (sacrum and both heels).
5) Patients who can lie on their side.
6) Patients with no history of skin problems caused by tape or dressings.
7) Patients who are hospitalized during the study period.
8) Patients who can give voluntary written consent from themselves if they are capable of consenting, or from a proxy if they lack capacity.
Key exclusion criteria
1) Patients who cannot obtain permission from their doctor.
2) Patients with skin damage at the measurement site.
3) Patients who are unable to lie on their side.
4) Patients with a history of skin problems caused by tape or dressings.
5) Patients who are allergic to the ingredients of the dressing materials.
6) Patients for whom it is difficult to draw the amount of blood required for the test.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Faculty of Health Science
Zip code
7558505
Address
1-1-1 Minamikogushi Ube Yamaguchi Japan
TEL
0836-22-2834
kenyama@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Fukumoto |
Organization
Ube West Rihabiritation Hospital
Division name
Nursing department
Zip code
7590202
Address
797 Okinodan Ube Yamaguchi Japan
TEL
0836-45-2111
Homepage URL
f006urw@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University
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
Yamaguchi University Graduate School of Medicine, Department of Health Sciences, Life Science and Medical Research Ethics Committee
Address
1-1-1 MInamikogushi Ube Yamaguchi Japan
Tel
0836-22-2111
me202@yamaguchi-u.ac.jp
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
| 2025 | Year | 06 | Month | 30 | 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
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066554
