UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032618 |
|---|---|
| Receipt number | R000037195 |
| Scientific Title | 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 00:10:43 |
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Basic information
Public title
Treatment of chronic wounds using FN coating wound bed combined with autologous skin cell suspension and Split-thickness skin grafting: A randomized controlled trial
Acronym
FN coating wound bed combined with autologous skin cell suspension and Split-thickness skin grafting for chronic wounds
Scientific Title
Treatment of chronic wounds using FN coating wound bed combined with autologous skin cell suspension and Split-thickness skin grafting: A randomized controlled trial
Scientific Title:Acronym
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® 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
| 1st name | |
| Middle name | |
| Last name | Jiayuan Zhu |
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 | Peng Wang |
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
wangp46@mail2.sysu.edu.cn
Sponsor or person
Institute
The First Affiliated Hospital of Sun Yat-sen University
Department of Burn Surgery
Institute
Department
Personal name
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)
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
| 2018 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2015 | Year | 12 | Month | 05 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037195
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