UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015000 |
|---|---|
| Receipt number | 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 18:29:06 |
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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'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
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
willway128@163.com
Sponsor or person
Institute
Zhu Jia-Yuan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017446
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
