UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014900 |
|---|---|
| Receipt number | R000017332 |
| Scientific Title | Research on the operation scar prevention method by taping |
| Date of disclosure of the study information | 2014/08/21 |
| Last modified on | 2014/08/23 06:24:03 |
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Basic information
Public title
Research on the operation scar prevention method by taping
Acronym
Research on the operation scar prevention method by taping
Scientific Title
Research on the operation scar prevention method by taping
Scientific Title:Acronym
Research on the operation scar prevention method by taping
Region
| Japan |
Condition
Condition
Postoperative scar
Classification by specialty
| Surgery in general | Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safty of Airwall and 3M micropor surgical tape on postoperativescar prevention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascularization of scar
Pigmentation of scar
hickeness of scar
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
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
| Medicine |
Interventions/Control_1
Airwall UV is stuck on the scar after removal of suture.
Interventions/Control_2
3M maicropor surgical tape is stuck on the scar after removal of suture.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients aged 16 and over who received the operation at the depertment of plastic and reconstructive surgery in the University of Tokyo.
Key exclusion criteria
1. A less than 16 year old patient
2.A patient who have less than 5cm of scar
3.A patient received operation on the face.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Yoshimura |
Organization
University of Tokyo School of Medicine
Division name
Plastic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan
TEL
81-3-5800-8948
kotaro-yoshimura@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Yoshimura |
Organization
University of Tokyo School of Medicine
Division name
Plasticand Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan
TEL
81-3-5800-8948
Homepage URL
kotaro-yoshimura@umin.ac.jp
Sponsor or person
Institute
Department of Plastic Surgery, University of Tokyo School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KYOWA CO. LIMITED
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
| 2014 | Year | 08 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017332
