UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028027
Receipt number R000032072
Scientific Title research about wound closure with micro auto skin graft
Date of disclosure of the study information 2017/06/30
Last modified on 2018/01/17 14:18:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

research about wound closure with micro auto skin graft

Acronym

micro auto skin graft

Scientific Title

research about wound closure with micro auto skin graft

Scientific Title:Acronym

micro auto skin graft

Region

Japan


Condition

Condition

skin ulcer

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of micro-auto skin graft to chronic skin ulcers

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate the wound healing 4 weeks after the grafting

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

skin grafting

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

18 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

systolic BP>=75mmHg,
diastolic BP<=100mmHg

Key exclusion criteria

diastolic BP>=120mmHg
severe liver or renal dysfunction
allergy
pregnant, lactation
who had other clinical research within 4 months

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sadanori Akita

Organization

Nagasaki university hospital

Division name

Plastic and reconstructive surgery

Zip code


Address

1-7-1 Sakamoto, Nagasaki-city

TEL

095-819-7328

Email

akitas@hf.rim.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masao Oishi

Organization

Nagasaki university hospital

Division name

Plastic and reconstructive surgery

Zip code


Address

1-7-1 Sakamoto, Nagasaki-city

TEL

095-819-7328

Homepage URL


Email

moishi@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki university

Institute

Department

Personal name



Funding Source

Organization

Nagasaki university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 30 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

Terminated

Date of protocol fixation

2016 Year 02 Month 16 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 30 Day

Last modified on

2018 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032072


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name