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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031258
Receipt No. 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

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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
Email 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
Email mokkox2@yahoo.co.jp

Sponsor
Institute Red Cross Maebashi Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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