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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025925
Receipt No. R000029810
Scientific Title Resistance test of dressing
Date of disclosure of the study information 2017/02/01
Last modified on 2017/01/31

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Basic information
Public title Resistance test of dressing
Acronym Resistance test of dressing
Scientific Title Resistance test of dressing
Scientific Title:Acronym Resistance test of dressing
Region
Japan

Condition
Condition healhealthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure volume of power that dressing materials lose fixation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We measure volume of power that dressing materials lose fixation, by force gauge.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 dressing 1
Interventions/Control_2 dressing 2
Interventions/Control_3 method 1 of fixation
Interventions/Control_4 method 2 of fixation
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 healthy volunteer
Key exclusion criteria Younger than 20 years
Past history with allergic of drug.
Skin disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Ouchi
Organization Kyushu University
Division name Dental
Zip code
Address 3-1-1, maidashi, higashi-ku, fukuoka
TEL 092-641-1151
Email ken2006anes@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Ouchi
Organization Kyushu University
Division name Dental
Zip code
Address 3-1-1, maidashi, higashi-ku, fukuoka
TEL 092-641-1151
Homepage URL
Email ken2006anes@yahoo.co.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Kyushu University
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
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 02 Month 01 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
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 31 Day
Last modified on
2017 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029810

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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