UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030953 |
|---|---|
| Receipt number | R000035324 |
| Scientific Title | A study of the wound healing effect on split thickness skin wound by Micro skin graft. |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2021/05/27 13:17:07 |
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Basic information
Public title
A study of the wound healing effect on split thickness skin wound by Micro skin graft.
Acronym
Wound healing by Micro skin graft
Scientific Title
A study of the wound healing effect on split thickness skin wound by Micro skin graft.
Scientific Title:Acronym
Wound healing by Micro skin graft
Region
| Japan |
Condition
Condition
split thickness skin wound
Classification by specialty
| Plastic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of micro-auto skin graft to chronic skin ulcers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the wound healing and scar until
6 months after the Micro skin grafting
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
control site
Interventions/Control_2
Micro skin grafting site
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo split thickness skin grafting
Key exclusion criteria
Patients with poor general condition
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Kashimura |
Organization
Nihon University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
1738610
Address
30-1 Ooyaguchikami-cho Itabashi-ku Tokyo
TEL
03-3972-8111
kashimura.tsutomu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Kashimura |
Organization
Nihon University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
1738610
Address
30-1 Ooyaguchikami-cho Itabashi-ku Tokyo
TEL
03-3972-8111
Homepage URL
kashimura.tsutomu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1 Ooyaguchikami-cho Itabashi-ku Tokyo Japan
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.ac.jp
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
| 2018 | Year | 01 | Month | 24 | 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
3
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
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035324
