UMIN-CTR Clinical Trial

Basic information
Public title	Disinfection and cross infection tests on sports equipment in covid-19 epidemic
Acronym	Disinfection & cross infection tests on sports equipment in covid-19
Scientific Title	Disinfection and cross infection tests on sports equipment in covid-19 epidemic
Scientific Title:Acronym	Disinfection & cross infection tests on sports equipment in covid-19
Region	Japan

Condition
Condition	Study 1) Healthy adults Study 2) Healthy adults (athletic members belonging to a specific sporting event)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is purpose to investigate over time whether disinfectants used to prevent infection will affect sports equipment and competition performance. In addition, purpose to investigate grasp the contact status of the cross-infected area, by wearing helmet (shields) and gloves to prevent droplets.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Observe the surface of the disinfecting area with the disinfecting solution under the conditions and take a photograph (electron microscope). 2) The area ratio (%) of the contact area and the ratio by contact area (times) are calculated by taking a picture.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	1) A sensory evaluation is performed on the feeling of touching the material to see if there is a tactile difference between the sports equipment without disinfection (control) and after disinfection, and depending on the disinfection conditions. 2) Wear test gloves on both hands and apply fluorescent paint. Repeatedly put on and take off the sports armor, and then shine a black light on the touched part. For mouthpieces, a cross-infection test is performed after containing food coloring water after wearing.
Interventions/Control_2
Interventions/Control_3
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) General healthy people (For Study 2, athletic club members belonging to sports sports) 2) Those who are 20 years of age or older at the time of obtaining consent 3) Persons who have received sufficient explanation before participating in this test, and who have obtained sufficient understanding and consent to the document at their own free will.
Key exclusion criteria	1) Persons who have difficulty in continuing measurement due to the progress of some disease or injury 2) Those who are judged by the participating doctors to discontinue measurement 3) Other subjects judged by the participating doctors to be inappropriate
Target sample size	41

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Fujiya
Organization	St. Marianna University School of Medicine
Division name	Department of Sports Medicine
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN
TEL	044-977-8111
Email	fujiya-1487@marianna-u.ac.jp

Public contact
Name of contact person	1st name Kanaka Middle name Last name Yatabe
Organization	St. Marianna University School of Medicine
Division name	Department of Sports Medicine
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN
TEL	044-977-8111
Homepage URL
Email	kanaka@marianna-u.ac.jp

Sponsor
Institute	Department of Sports Medicine, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Department of Sports Medicine, St. Marianna University School of Medicine
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	Graduate School & Research Promotion Division, St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN
Tel	044-977-8111
Email	k-shienbu.mail@marianna-u.ac.jp

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	2020 Year 12 Month 09 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 28 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 28 Day
Last modified on	2020 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048258

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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