UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of chronic wounds using FN coating wound bed combined with autologous skin cell suspension and Split-thickness skin grafting: A randomized controlled trial
Title of the study (Brief title)	FN coating wound bed combined with autologous skin cell suspension and Split-thickness skin grafting for chronic wounds
Region	Asia(except Japan)

Condition
Condition	Treatment of chronic wounds is a big clinically challenging based on low graft take rates associated with current surgery, and the cell utilization and therapeutic effects for chronic wounds need to be improved.
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Treatment of chronic wounds is a big challenging based on low graft take rates. Our previous study had verified the combined approach of surgical split-thickness skin autograft with ReCell&reg can improve the treatment effects. However, our recent study has found the cell utilization can be further improved.Here, we investigated whether FN coating wound bed combined with autologous skin cell suspension and Split-thickness skin grafting can improve the cell utilization and therapeutic effects for the chronic wounds.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of complete wound healing at 28 days (full re-epithelialization, without any requirement for dressing)
Key secondary outcomes	The time to achieve complete wound closure and treatment-related complications, included pain and itching

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	patients received FN coating wound bed combined with autologous skin cell suspension and Split-thickness skin grafting (experimental group)
Interventions/Control_2	patients received autologous skin cell suspension and Split-thickness skin grafting(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 with a chronic wound (defined as a wound that remained unhealed for more than 4 weeks) which required surgical debridement and skin grafting were eligible.
Key exclusion criteria	1.Pregnant women and people aged less than 18 years old; 2.Pre-existing medical conditions that could potentially interfere with wound healing; 3.Patients diagnosed with other medical conditions that could hinder wound healing. 4.Patients considered to be at an aesthetic risk and refusal to give consent.
Target sample size	102

Research contact person
Name of lead principal investigator	Jiayuan Zhu
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	Peng Wang
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	wangp46@mail2.sysu.edu.cn

Sponsor
Institute	The First Affiliated Hospital of Sun Yat-sen University Department of Burn Surgery
Institute
Department

Funding Source
Organization	National Natural Science Foundation of China (No. 81471875), 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	2018 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 05 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2017 Year 12 Month 10 Day
Date of closure to data entry	2018 Year 02 Month 01 Day
Date trial data considered complete	2018 Year 02 Month 01 Day
Date analysis concluded	2018 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 17 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037195