UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015428
Receipt number R000017940
Scientific Title EPINEXUSTM Skin Adhesive Pilot Study to Evaluate Efficacy and Safety: Single-center, Open-label, Single-arm Study
Date of disclosure of the study information 2014/10/15
Last modified on 2017/09/12 13:04:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

EPINEXUSTM Skin Adhesive Pilot Study to Evaluate Efficacy and Safety:
Single-center, Open-label, Single-arm Study

Acronym

EPINEXUSTM Pilot Study

Scientific Title

EPINEXUSTM Skin Adhesive Pilot Study to Evaluate Efficacy and Safety:
Single-center, Open-label, Single-arm Study

Scientific Title:Acronym

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

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

nonken@2001.jukuin.keio.ac.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 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


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

2014 Year 10 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.scirp.org/Journal/PaperInformation.aspx?PaperID=78499

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

2014 Year 09 Month 29 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017940


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name