UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039558 |
|---|---|
| Receipt number | R000045110 |
| Scientific Title | Investigation on disinfecting effect by difference of detergent and damaging action for fingers in operation department |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2020/08/24 11:24:14 |
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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
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
pswrrakita@gmail.com
Sponsor or person
Institute
Department of Plastic Surgery, Wound Repair and Generation, Fukuoka University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045110
