UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051955