UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006418 |
|---|---|
| Receipt number | R000007610 |
| Scientific Title | Establishment of a regenerative medicine to accelerate the re-epithelialization in acute or chronic wounds by means of a microskin grafting and administration of Fiblast Spray (bFGF) |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2012/03/09 09:56:22 |
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Basic information
Public title
Establishment of a regenerative medicine to accelerate the re-epithelialization in acute or chronic wounds by means of a microskin grafting and administration of Fiblast Spray (bFGF)
Acronym
Establishment of a regenerative medicine to accelerate the re-epithelialization in acute or chronic wounds
Scientific Title
Establishment of a regenerative medicine to accelerate the re-epithelialization in acute or chronic wounds by means of a microskin grafting and administration of Fiblast Spray (bFGF)
Scientific Title:Acronym
Establishment of a regenerative medicine to accelerate the re-epithelialization in acute or chronic wounds
Region
| Japan |
Condition
Condition
Acute wounds:burns, donor site wounds
Chronic wounds:pressure ulcers
Classification by specialty
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish an effective and easy regenerative medicine for acceleration of the re-epithelialization in acute or chronic wounds
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Speed of the re-epithelialization (days until completion of the re-epithelialization)
2. Appearance, quality (thickness, viscoelasticity) and contraction rate of the healed skin after completion of the re-epithelialization
3. Histological findings
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
A group:conservative management, once a day, until completion of the re-epithelialization
Interventions/Control_2
B group:administration of Fiblast Spray only, once a day, until completion of the re-epithlialization
Interventions/Control_3
C group:microskin grafting only, once
Interventions/Control_4
D group:microskin grafting, once + fiblast Spray, once a day, until completion of the re-epithlialization
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute wounds:burns, donor site wounds
Chronic wounds:pressure ulcers
Key exclusion criteria
Patients who have complications of 1) Malignancy, 2) Severe systemic illness affecting the liver, kidney, lung, heart, blood, brain and neurological systems
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyoko Kubo |
Organization
Kawasaki Medical School
Division name
Plastic and Reconstructive Surgery
Zip code
Address
577 Matsushima, Kurashiki City, Okayama 701-0192, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kawasaki Medical School
Division name
Plastic Surgery, Aesthetic Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Miyoko Kubo
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
| 2012 | Year | 01 | Month | 01 | 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
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | 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
| 2011 | Year | 09 | Month | 27 | Day |
Last modified on
| 2012 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007610
