UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026039 |
|---|---|
| Receipt number | R000029863 |
| Scientific Title | OASIS extracellular matrix clinical efficacy study |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2018/08/10 20:02:28 |
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Basic information
Public title
OASIS extracellular matrix clinical efficacy study
Acronym
OASIS study
Scientific Title
OASIS extracellular matrix clinical efficacy study
Scientific Title:Acronym
OASIS study
Region
| Japan |
Condition
Condition
patient having donor site for split-thickness skin graft
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of OASIS extracellular matrix efficacy for donor site for split-thickness skin graft
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pathologic evaluation of donor site after healing
Key secondary outcomes
time to healing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
half side test of extracellular matrix and conventional treatment for split thickness donor site.
the term of intervention is until healing of donor site.
biopsy of donor sites applied OASIS and conventional treatment after healing.
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
patients having split thickness donor site
Key exclusion criteria
infectious wound
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yutaro yamashita |
Organization
kyorin university hospital
Division name
plastic surgery
Zip code
Address
2-2, sinkawa 6-chome, mitaka, tokyo, japan
TEL
0422-47-5511
thestarstripjp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yutaro yamashita |
Organization
kyorin university hospital
Division name
plastic surgery
Zip code
Address
2-2, sinkawa 6-chome, mitaka, tokyo, japan
TEL
0422-47-5511
Homepage URL
thestarstripjp@yahoo.co.jp
Sponsor or person
Institute
kyorin university hospital
Institute
Department
Personal name
Funding Source
Organization
kyorin university hospital department of plastic surgery
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
杏林大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | 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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029863
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
