UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031258 |
|---|---|
| Receipt number | R000035690 |
| Scientific Title | Using of a combination of meshed dermis graft and cultured epithelial autograft for massive burned patients |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2020/02/14 23:11:03 |
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Basic information
Public title
Using of a combination of meshed dermis graft and cultured epithelial autograft for massive burned patients
Acronym
Combination of meshed dermis graft and cultured epithelial autograft
Scientific Title
Using of a combination of meshed dermis graft and cultured epithelial autograft for massive burned patients
Scientific Title:Acronym
Combination of meshed dermis graft and cultured epithelial autograft
Region
| Japan |
Condition
Condition
Burn
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When we use cultured epithelial autograft (CEA) for massive burns, we conbine meshed skin graft and CEA. This method is better rate of engraft than using CEA only.
Dr. Hayashi reported the dermis make the CEA bind to the burn wound in 2016.
So we search using of a combination of meshed dermis graft and cultured epithelial autograft for massive burned patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
We assessed the rate of engraft on post operating 3 weeks and 6 weeks.
Key secondary outcomes
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
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Using of a combination of meshed dermis graft and cultured epithelial autograft for massive burned patients
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
massive burn
Key exclusion criteria
local burn
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Hayashi |
Organization
Red Cross Maebashi Hospital
Division name
Dept. Plastic, Reconstructive and Aesthetic Surgery
Zip code
3710014
Address
3-21-36 Asahi-cho, Maebashi-shi, Gunma, Japan
TEL
027-224-4585
mokkox2@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Hayashi |
Organization
Red Cross Maebashi Hospital
Division name
Dept. Plastic, Reconstructive and Aesthetic Surgery
Zip code
3710014
Address
3-21-36 Asahi-cho, Maebashi-shi, Gunma, Japan
TEL
027-224-4585
Homepage URL
mokkox2@yahoo.co.jp
Sponsor or person
Institute
Red Cross Maebashi Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Red Cross Maebashi Hospital
Address
3-21-36 Asahi-cho, Maebashi-shi, Gunma, Japan
Tel
027-224-4585
mokkox2@yahoo.co.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
前橋赤十字病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 03 | 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 | 02 | Month | 12 | Day |
Last modified on
| 2020 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035690
