UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000035690