UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046195 |
|---|---|
| Receipt number | R000051955 |
| Scientific Title | The 180-degree peel adhesion test from human skin for antimicrobial adhesive polyurethane gel sheet |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2022/05/28 13:55:51 |
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Basic information
Public title
Assessment of adhesiveness to skin of antimicrobial adhesive polyurethane gel sheet for silicone mammary prostheses fastening
Acronym
Assessment of adhesiveness to skin of antimicrobial adhesive polyurethane gel sheet for silicone mammary prostheses fastening
Scientific Title
The 180-degree peel adhesion test from human skin for antimicrobial adhesive polyurethane gel sheet
Scientific Title:Acronym
The 180-degree peel adhesion test from human skin for antimicrobial adhesive polyurethane gel sheet
Region
| Japan |
Condition
Condition
Breast loss
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of adhesiveness to skin of antimicrobial adhesive polyurethane gel sheet for silicone mammary prostheses fastening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The 180-degree peel adhesive force from human skin
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1. The polyurethane gel sheets with 0(control), 2, 5, 10, 15 wt.% cetylpyridinium chloride-montmorillonite as a antimicrobial agent
2. Five sheets: width, 25 mm; length, 200 mm; thickness, 1 mm
3. The 180-degree peel adhesion test time per a sheet from human skin X 5 times
4. The objective area of human skin: a flat skin in the ulna part side of left forearm
Interventions/Control_2
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The volunteers of 25 to 60 years-old
2. The volunteers with a written consent for this study
Key exclusion criteria
1. The persons with skin disease or allergic symptoms
2. The inappropriate persons judged by a principal investigator or contributors
3. The disinterested persons who don't attend the lecture by the principal investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Abe |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Advanced Prosthodontics
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5677
abey@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Abe |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Advanced Prosthodontics
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5677
Homepage URL
abey@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel
082-257-1947
iryo-seisaku@office.hiroshima-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
広島大学大学院医系科学研究科先端歯科補綴学研究室（広島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
| 2021 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 26 | Day |
Last modified on
| 2022 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051955
