UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the antimicrobial activity of the antibacterial peptide fiber
Title of the study (Brief title)	kabutomushi study
Region	Japan

Condition
Condition	infection contorol
Classification by specialty	Infectious disease Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Confirm the effect in the healthcare setting of the processing cloth sample using the antibacterial peptide
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decrease in bacteria pollution
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Antibacterial fiber wearing group
Interventions/Control_2	Non-antibacterial fiber wearing group
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Physical Therapist
Key exclusion criteria	Poor adherence to the treatment
Target sample size	20

Research contact person
Name of lead principal investigator	Keiichiro Akamatsu
Organization	Wakayama Medical University Hospital
Division name	Department of Infection control
Address	Kimiidera811-1, Wakayama
TEL	0734472300(2494)
Email	akamatsu@wakayama-med.ac.jp

Public contact
Name of contact person	Keiichiro Akamatsu
Organization	Wakayama Medical University Hospital
Division name	Department of Infection control
Address	Kimiidera811-1, Wakayama
TEL	0734472300(2494)
Homepage URL
Email	akamatsu@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University Hospital Department of Infection control
Institute
Department

Funding Source
Organization	Shin-Nakamura Chemical Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2014 Year 02 Month 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 25 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014826