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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029121
Receipt No. 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

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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
Email 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
Email handbal1016@yahoo.co.jp

Sponsor
Institute Tokyo City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033302

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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