UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029121 |
|---|---|
| Receipt number | R000033302 |
| Scientific Title | Treatment strategies for acute wounds by cold atmospheric pressure plasma:Prospective study on wound healing after fractional laser irradiation |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2018/05/29 14:32:39 |
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Basic information
Public title
Treatment strategies for acute wounds by cold atmospheric pressure plasma:Prospective study on wound healing after fractional laser irradiation
Acronym
Treatment strategies for acute wounds by cold atmospheric pressure plasma
Scientific Title
Treatment strategies for acute wounds by cold atmospheric pressure plasma:Prospective study on wound healing after fractional laser irradiation
Scientific Title:Acronym
Treatment strategies for acute wounds by cold atmospheric pressure plasma
Region
| Japan |
Condition
Condition
Wounds after fractional laser irradiation
Classification by specialty
| Dermatology | Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of usefulness of cold atmospheric pressure plasma on wound area after fractional laser irradiation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of pigmentation after 3 months
Key secondary outcomes
Evaluation of transpiration of skin
Evaluation of skin barrier function
Evaluation of downtime
(all after 3 months)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CO2 fractional lasers are irradiated to the inside of the left forearm at 1*1 cm (Power: 10 W, Dwell time: 600 ys, Spacing: 650 ym)
(1)a control group in which no post-treatment is performed
Interventions/Control_2
(2)a group in which bFGF is sprayed once immediately after irradiation90 days.
Interventions/Control_3
(3)a group in which plasma is irradiated for 30 seconds.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) According to the protocol of this study, subjects irradiated with fractional laser
2) After receiving sufficient explanation for the participation of this research, after having sufficient understanding, the examinees who obtained document agreement by the subject's free will
Key exclusion criteria
1) Subjects withdrew consent during and after the test
2) Subject having a history of hypersensitivity to medical plasma
3) Subjects who have either diabetes, ischemic disease, collagen disease, oral history of steroids
4) Other subjects whose examination director judged inappropriate as subjects
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AKIO NISHIJIMA |
Organization
Tokyo City University
Division name
Department of Medical Engineering, Faculty of Engineering
Zip code
Address
158- 8557 1-28-1 of Tamadutumi Setagaya-ku, Tokyo
TEL
090-6256-5606
handbal1016@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AKIO NISHIJIMA |
Organization
Tokyo City University
Division name
Department of Medical Engineering, Faculty of Engineering
Zip code
Address
158- 8557 1-28-1 of Tamadutumi Setagaya-ku, Tokyo
TEL
090-6256-5606
Homepage URL
handbal1016@yahoo.co.jp
Sponsor or person
Institute
Tokyo City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
ClinicF
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
| 2017 | Year | 09 | Month | 15 | 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
| 2017 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 29 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 13 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033302
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
