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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032618
Receipt No. R000037195
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
Date of disclosure of the study information 2018/05/17
Last modified on 2018/05/17

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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