UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015974 |
|---|---|
| Receipt number | R000018579 |
| Scientific Title | Split Thickness Skin Grafft Re-epitelialization of Platelet Rich Plasma and Fragmin / Protamine nano pariticle |
| Date of disclosure of the study information | 2014/12/17 |
| Last modified on | 2016/03/30 10:45:24 |
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Basic information
Public title
Split Thickness Skin Grafft Re-epitelialization of Platelet Rich Plasma and Fragmin / Protamine nano pariticle
Acronym
STSG Re-epitelialization of PRP and F/P nano particle
Scientific Title
Split Thickness Skin Grafft Re-epitelialization of Platelet Rich Plasma and Fragmin / Protamine nano pariticle
Scientific Title:Acronym
STSG Re-epitelialization of PRP and F/P nano particle
Region
| Japan |
Condition
Condition
patients undergoing split thickness skin graft surgery
Classification by specialty
| Surgery in general | Dermatology | Plastic surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is assume re-epithelialization of PRP and F/P nano particle
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
re-epitheliazation rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
application of Platelet Rich Plasma and Fragmin Protamine nano particle
Interventions/Control_2
application of PRP
Interventions/Control_3
application of F/P nano particle
Interventions/Control_4
application of natural saline
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing split thickness skin graft surgery
Key exclusion criteria
severe anemia
severe kidney disease
severe liver disease
immune abnormarity
severe diabetes
coagulation abnormarity
plegnant woman
Subjects whose doctor in charge do not agree to join the trial
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Takabayashi |
Organization
National Defense Medical College
Division name
Department of Plastic surgery
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2997-5156
drpl002@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Takabayashi |
Organization
National Defense Medical College
Division name
Department of Plastic surgery
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2997-5156
Homepage URL
drpl002@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 17 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018579
