UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment strategies for acute wounds by cold atmospheric pressure plasma:Prospective study on wound healing after fractional laser irradiation
Title of the study (Brief title)	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	AKIO NISHIJIMA
Organization	Tokyo City University
Division name	Department of Medical Engineering, Faculty of Engineering
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	AKIO NISHIJIMA
Organization	Tokyo City University
Division name	Department of Medical Engineering, Faculty of Engineering
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033302