UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016753 |
|---|---|
| Receipt number | 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 21:36:07 |
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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
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
nonken@2001.jukuin.keio.ac.jp
Sponsor or person
Institute
Keio university, school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019440
