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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016753
Receipt No. R000019440
Scientific Title A comparative study of EPINEXUSTM and Commercial Skin Adhesive in patients undergoing surgery: Single Center, Open-Label, Parallel Group Study
Date of disclosure of the study information 2015/03/15
Last modified on 2019/09/14

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Basic information
Public title A comparative study of EPINEXUSTM and Commercial Skin Adhesive in patients undergoing surgery:
Single Center, Open-Label, Parallel Group Study
Acronym Clinical comparative study of EPINEXUSTM and Commercial product
Scientific Title A comparative study of EPINEXUSTM and Commercial Skin Adhesive in patients undergoing surgery:
Single Center, Open-Label, Parallel Group Study
Scientific Title:Acronym Clinical comparative study of EPINEXUSTM and Commercial product
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy and esthetics results of the incision wound using epinexusTM vs Commercial Skin Adhesive
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cosmetic outcome of wound
Key secondary outcomes wound closure rate
usability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 wound closure with EPINEXUSTM for incision wound
Interventions/Control_2 wound closure with Commercial Skin Adhesive for incision wound
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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kishi
Organization Keio university, school of medicine
Division name Plastic and reconstructivve surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku
TEL 03-5363-3814
Email kkishi@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Aramaki
Organization Keio university, school of medicine
Division name Plastic and reconstructivve surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 03 Month 15 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 Completed
Date of protocol fixation
2015 Year 03 Month 02 Day
Date of IRB
2015 Year 02 Month 23 Day
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2018 Year 12 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
2015 Year 03 Month 09 Day
Last modified on
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019440

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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