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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046195
Receipt No. 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 2021/11/26

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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
Email 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
Email abey@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email 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 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 Open public recruiting
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
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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