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

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 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

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

Value
https://center6.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