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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015000
Receipt No. R000017446
Scientific Title Treatment of donor sites using a non cultured autologous cell suspension: A randomized controlled trial
Date of disclosure of the study information 2014/09/10
Last modified on 2016/08/21

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Basic information
Public title Treatment of donor sites using a non cultured autologous cell suspension: A randomized controlled trial
Acronym a non cultured autologous cell suspension treated donor sites
Scientific Title Treatment of donor sites using a non cultured autologous cell suspension: A randomized controlled trial
Scientific Title:Acronym a non cultured autologous cell suspension treated donor sites
Region
Asia(except Japan)

Condition
Condition people who had donor site after skin grafted
Classification by specialty
Dermatology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of a non cultured autologous cell suspension used in donor site of skin graft.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes healing time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ReCell group
Interventions/Control_2 control group
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who required skin grafting and donor site covered.
Key exclusion criteria Exclusion criteria consisted in the presence of pre-existing local and systemic bacterial infections, pre-existing medical conditions that would interfere with wound healing (diabetes, malignancy, autoimmune disease), renal failure (glomerular filtration rate inferior to 60 ml/min), medications that could interfere with wound healing (corticosteroids), hypersensitivity to Trypsin or Hartmann&#39;s solution, a high anesthesiology risk that necessarily postponed surgery.
Target sample size 106

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Zhu Jia-Yuan
Organization The First Affiliated Hospital of Sun Yat-sen University
Division name Department of Burn Surgery
Zip code
Address 58 Zhongshan Road II, Guangzhou 510080, China
TEL 86-20-87755766-8235
Email zhujiay@mail.sysu.edu.cn

Public contact
Name of contact person
1st name
Middle name
Last name Hu Zhi-Cheng
Organization The First Affiliated Hospital of Sun Yat-sen University
Division name Department of Burn Surgery
Zip code
Address 58 Zhongshan Road II, Guangzhou 510080, China
TEL 86-20-87755766-8235
Homepage URL
Email willway128@163.com

Sponsor
Institute Zhu Jia-Yuan
Institute
Department

Funding Source
Organization National Natural Science Foundation of China (No. 81272096), Sun Yat-sen University Clinical Research 5010 Program (No. 2013001)
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
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
2014 Year 09 Month 10 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
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
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 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
2014 Year 08 Month 30 Day
Last modified on
2016 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017446

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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