UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051397 |
|---|---|
| Receipt number | R000058518 |
| Scientific Title | Efficacy of hand antiseptics (Malclean 0.02% solution) to remove Serratia marcescens from contaminated hands |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/06/20 11:57:30 |
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Basic information
Public title
Efficacy of hand antiseptics (Malclean 0.02% solution) to remove Serratia marcescens from contaminated hands
Acronym
Hand antiseptics
Scientific Title
Efficacy of hand antiseptics (Malclean 0.02% solution) to remove Serratia marcescens from contaminated hands
Scientific Title:Acronym
Hand hygiene
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hand hygiene
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bactericidal effect
Key secondary outcomes
Viable count of Serratia marcescens
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy hand
Key exclusion criteria
Dermatitis
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Shigeharu |
| Middle name | |
| Last name | Oie |
Organization
Sanyo-Onoda City University
Division name
Faculty of Pharmaceutical Sciences
Zip code
756-0884
Address
1-1-1, Daigakudori, Sanyo-Onoda, Yamaguchi
TEL
0836-39-9156
oie@rs.socu.ac.jp
Public contact
Name of contact person
| 1st name | Shigeharu |
| Middle name | |
| Last name | Oie |
Organization
Sanyo-Onoda City University
Division name
Faculty of Pharmaceutical Sciences
Zip code
756-0884
Address
1-1-1, Daigakudori, Sanyo-Onoda, Yamaguchi
TEL
0836-39-9156
Homepage URL
oie@rs.socu.ac.jp
Sponsor or person
Institute
Sanyo-Onoda City University
Institute
Department
Personal name
Shigeharu Oie
Funding Source
Organization
Maruclean Co.
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
Yamaguchi Tokyo University of Science Ethics Review Committee for Life Science and Medical Research on Human Subjects
Address
1-1-1, Daigakudori, Sanyo-Onoda, Yamaguchi
Tel
0836-88-4501
kimura_masaaki@admin.socu.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
| 2023 | Year | 08 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Bactericidal activity of hand antiseptics (Malclean 0.02% solution) against Serratia marcescens attached to hands
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058518
| 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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| Registered date | File name |
