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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000046677 |
Receipt No. | 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 | 2022/05/08 |
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 |
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Condition | ||
Condition | healthy adult | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | perfomance status 0
persons with written consent |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Japanese Red Cross Shizuoka Hospital |
Institute | |
Department |
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 |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052864 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |