UMIN-CTR Clinical Trial

Basic information
Public title	Effects of operation hand-washing procedures on hand hygiene Survey by palm stamp
Acronym	Effects of operation hand-washing procedures on hand hygiene Survey by palm stamp
Scientific Title	Effects of operation hand-washing procedures on hand hygiene Survey by palm stamp
Scientific Title:Acronym	Effects of operation hand-washing procedures on hand hygiene Survey by palm stamp
Region	Japan

Condition
Condition	All patients undargoing surgery
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the difference of operation hand-washing procedure methods between two-stage scrub and alcohol-based handrub by palm stamp
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Detection of normal flora and transient micro-organisms before and after two stage method scrub procedure
Key secondary outcomes	Two-stage scrub method is equivalent to alcohol-based handrub.

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Total 9 minutes intervention requires; 1 minute befor hand washing, 1 minute after scurbbing procedure, 6 minutes after palm stamp survey, and 1 minute just after taking off the surgical gloves.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Medical doctors in Tohoku University hospital scrubbing their hands
Key exclusion criteria	None
Target sample size	51

Research contact person
Name of lead principal investigator	1st name sato Middle name Last name yuko
Organization	nursing department
Division name	opration division
Zip code	980-8574
Address	sendaishi aobaku seiryoumachi 1-1
TEL	022-717-7403
Email	miki.wako.d7@Tohoku.ac.jp

Public contact
Name of contact person	1st name miki Middle name Last name wako
Organization	nursing department
Division name	opration division
Zip code	980-8574
Address	sendaishi aobaku seiryoumachi 1-1
TEL	022-717-7403
Homepage URL
Email	miki.wako.d7@Tohoku.ac.jp

Sponsor
Institute	tohoku university hospital operation division
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	opration division
Address	sendaishi aobaku seiryoumachi 1-1
Tel	022-717-7403
Email	miki.wako.d7@Tohoku.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	2019 Year 10 Month 24 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	No longer recruiting
Date of protocol fixation	2018 Year 12 Month 10 Day
Date of IRB	2021 Year 02 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 24 Day
Last follow-up date	2019 Year 10 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 19 Day
Last modified on	2021 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043667