UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014551 |
|---|---|
| Receipt number | R000016929 |
| Scientific Title | A study regarding arrangement of skin fibers |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2022/08/26 07:40:55 |
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Basic information
Public title
A study regarding arrangement of skin fibers
Acronym
A study of skin fibers
Scientific Title
A study regarding arrangement of skin fibers
Scientific Title:Acronym
A study of skin fibers
Region
| Japan |
Condition
Condition
cases who have skin to be excised intraoperatively
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate 3 dimensional arrangement of collagen and elastic fibers involved in the matrix components in the human skin, and to analyze the relation between these fibers and skin elasticity.
Basic objectives2
Others
Basic objectives -Others
Pathological analysis for arrangement of fibers in the subcutaneous layer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3 dimensional arrangement of collagen and elastic fibers involved in the matrix components in the human skin, and the relation between these fibers and skin elasticity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cases who have the skin larger than 5 mm in diameter to be excised intraoperatively, and it is possible to obtain informed consent for the study.
Patients, who are younger than 7 years, informed consent from their parents should be obtained.
Key exclusion criteria
Subjects from whom informed consent or assent cannot be obtained.
Patients are younger than 7 years, it is not possible to obtain informed consent from their parents
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Saito |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3613
susumus@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Saito |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3613
Homepage URL
susumus@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization
Other
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 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
3 dimensional arrangement of collagen and elastic fibers involved in the matrix components in the human skin, and the relation between these fibers and skin elasticity
Management information
Registered date
| 2014 | Year | 07 | Month | 14 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016929
