UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046677 |
|---|---|
| Receipt number | R000052864 |
| Scientific Title | The study of completion rate and safety of wearing surgical gloves for four hours. |
| Date of disclosure of the study information | 2022/01/20 |
| Last modified on | 2023/03/10 13:20:39 |
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Basic information
Public title
The study of completion rate and safety of wearing surgical gloves for four hours.
Acronym
The study of completion rate and safety of wearing surgical gloves for four hours.
Scientific Title
The study of completion rate and safety of wearing surgical gloves for four hours.
Scientific Title:Acronym
The study of completion rate and safety of wearing surgical gloves for four hours.
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze safety of wearing surgical gloves to avoid chemotherapy induced peripheral neuropathy for four hours.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
completion rate
Key secondary outcomes
adverse events more than grade 2 of CTCAE during or after this intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing two layers of surgical gloves whose size is one size smaller for four hours.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
perfomance status 0
persons with written consent
Key exclusion criteria
any prior chemotherapy
peripheral neuropathy
active thrombosis
person whose right size of surgical gloves is less than 5.5 or more than 8.5
person who is regarded inappropriate for this study by doctors in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Kurihara |
Organization
Japanese Red Cross Shizuoka Hospital
Division name
Obstetrics and Gynecology
Zip code
420-0853
Address
8-2 Ote-machi, Aoi Ward, Shizuoka City, Shizuoka Prefecture
TEL
054-254-4311
mizumizuki0130@gmail.com
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Kurihara |
Organization
Japanese Red Cross Shizuoka Hospital
Division name
Obstetrics and Gynecology
Zip code
420-0853
Address
8-2 Ote-machi, Aoi Ward, Shizuoka City, Shizuoka Prefecture
TEL
054-254-4311
Homepage URL
mizumizuki0130@gmail.com
Sponsor or person
Institute
Japanese Red Cross Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Shizuoka Hospital
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
Japanese Red Cross Shizuoka Hospital
Address
8-2 Ote-machi, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Tel
054-254-4311
chiken-srhpp@wonder.ocn.ne.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
静岡赤十字病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 20 | 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
20
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
| 2021 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 19 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052864
