UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030921 |
|---|---|
| Receipt number | R000035310 |
| Scientific Title | Comparison of 1% and 0.5% chlorhexidine in the alcohol-based hand rubbing method for surgical hand antisepsis |
| Date of disclosure of the study information | 2018/01/22 |
| Last modified on | 2019/07/24 12:19:22 |
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Basic information
Public title
Comparison of 1% and 0.5% chlorhexidine in the alcohol-based hand rubbing method for surgical hand antisepsis
Acronym
chlorhexidine in the rubbing methods
Scientific Title
Comparison of 1% and 0.5% chlorhexidine in the alcohol-based hand rubbing method for surgical hand antisepsis
Scientific Title:Acronym
chlorhexidine in the rubbing methods
Region
| Japan |
Condition
Condition
nursing stuff in the operating department
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of chlorhexidine in the alcohol-based hand rubbing method for surgical hand antisepsis of the operating nursing stuffs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of bacteria remained on the hands after 3 hours
Key secondary outcomes
skin condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1% chlorhexidine
Interventions/Control_2
0.5% chlorhexidine
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
operating nursing stuffs
Key exclusion criteria
hypersensitivity to alcohol
rough hands
exposure to alcohol to hands within 24 hrs
exposure to the conditions in which many bacterias within 24 hrs.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Nagase |
Organization
Gifu University Hospital
Division name
Operating division
Zip code
Address
1-1 Yanagido, Gifu City
TEL
0582307888
kiyoshi@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Nagase |
Organization
Gifu University Hospital
Division name
Operating division
Zip code
Address
1-1 Yanagido, Gifu City
TEL
0582307888
Homepage URL
kiyoshi@gifu-u.ac.jp
Sponsor or person
Institute
Operating Division
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Operating Division
Gifu University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saraya Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 22 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 08 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2019 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035310
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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