UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of donor sites using a non cultured autologous cell suspension: A randomized controlled trial
Title of the study (Brief title)	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	Zhu Jia-Yuan
Organization	The First Affiliated Hospital of Sun Yat-sen University
Division name	Department of Burn Surgery
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	Hu Zhi-Cheng
Organization	The First Affiliated Hospital of Sun Yat-sen University
Division name	Department of Burn Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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