UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	EPINEXUSTM Skin Adhesive Pilot Study to Evaluate Efficacy and Safety: Single-center, Open-label, Single-arm Study
Title of the study (Brief title)	EPINEXUSTM Pilot Study
Region	Japan

Condition
Condition	operation wound
Classification by specialty	Breast surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of epinexusTM
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	wound closure scar

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	wound closure for incision wound
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient who receive tumor resection by plastic surgeon or breast surgeon
Key exclusion criteria	allergy for methyl methacrylate skin disease keloid
Target sample size	5

Research contact person
Name of lead principal investigator	Kazuo Kishi
Organization	Keio university, school of medicine
Division name	Plastic and reconstructivve surgery
Address	35 Shinanomachi, Shinjuku-ku
TEL	03-5363-3814
Email	nonken@2001.jukuin.keio.ac.jp

Public contact
Name of contact person	Noriko Aramaki
Organization	Keio university, school of medicine
Division name	Plastic and reconstructivve surgery
Address	35 Shinanomachi, Shinjuku-ku
TEL	03-5363-3814
Homepage URL
Email	nonken@2001.jukuin.keio.ac.jp

Sponsor
Institute	Keio university, school of medicine
Institute
Department

Funding Source
Organization	Mitsui Chemicals, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 29 Day
Anticipated trial start date	2014 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry	2017 Year 09 Month 02 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.scirp.org/Journal/PaperInformation.aspx?PaperID=78499
Results
Other related information

Management information
Registered date	2014 Year 10 Month 14 Day
Last modified on	2017 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017940