UMIN-CTR Clinical Trial

Basic information
Public title	Investigation on disinfecting effect by difference of detergent and damaging action for fingers in operation department
Acronym	Detergent Study
Scientific Title	Investigation on disinfecting effect by difference of detergent and damaging action for fingers in operation department
Scientific Title:Acronym	Detergent Study
Region	Japan

Condition
Condition	Healthy volunteers (nurses working full-time in surgical wards)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To collect the data that the hand-washing with additive-free soap shall be available in preoperation hand-washing, and to investigate the availability
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of bacterium number decreasing rate between immediately after washing and after surgery duties in water-less method user group
Key secondary outcomes	1. Water content of stratum corneum 2. Score for Rough hands 3.Score for impression of use

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Study 1 Group A: Water-less method Group B: Two-stage method [hand-washing with soap] and [disinfection with alcohol] are performed in water-less method, and [hand-washing with scrubbing agent] and [disinfection with alcohol] are performed in two-stage method.
Interventions/Control_2	Study 2 Group A: Two-stage method Group B: Water-less method An interval period of at least 10 days is established between study 1 and study 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. Nurses providing the written informed consent for participating in this study 2. Nurses working full-time in surgical wards 3. Nurses engaging in operation of wound classification Class I or II for around 1 hour or more than 1hour (upper limit 4 hours) 4. Nurses who use chlorhexidine alone as a scrub agent or disinfectant in ordinary hand-washing before operation 5. Nurses are >=20 years of age at the time of informed consent
Key exclusion criteria	1. Nurses with severe skin rash in the hand and fingers (in score 3 and 4 in Atopic dermatitis guideline 2018 below) 2. Nurses engaging in activities which causes rough hands and injury exceeding ordinary duties or house works in daily life 3. Nurses using hand cream containing steroid 4. Nurses with skin diseases in forearms, hands and fingers. 5. Nurses who recently injure a washing part and who use oral medicines or external preparations for treatment of burn injury, ulcer, bleeding, connective tissue disease and systemic metabolic disease 6. Nurses medicated with anti-coagulant, anti-platelet or immunosuppressant including steroids 7. Nurses using drugs interfering this study by the judgment of their own family doctor
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Sadanori Middle name Last name Akita
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Plastic Surgery, Wound Repair and Generation
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan
TEL	092-866-8250
Email	akitas@hf.rim.or.jp

Public contact
Name of contact person	1st name Kumiko Middle name Last name Hayashi
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Plastic Surgery, Wound Repair and Generation
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan
TEL	092-866-8250
Homepage URL
Email	pswrrakita@gmail.com

Sponsor
Institute	Department of Plastic Surgery, Wound Repair and Generation, Fukuoka University Faculty of Medicine
Institute
Department

Funding Source
Organization	Shabondama Soap Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Support Center Kyushu
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582 Japan
Tel	092-631-2920
Email	info1@cres-kyushu.or.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	福岡大学病院（福岡県）、長崎医療センター（長崎県）

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 21 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	36
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	2020 Year 01 Month 10 Day
Date of IRB	2020 Year 01 Month 31 Day
Anticipated trial start date	2020 Year 02 Month 03 Day
Last follow-up date	2020 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 02 Month 21 Day
Last modified on	2020 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045110