UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email 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
Email 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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 19 Day
Last modified on
2022 Year 05 Month 08 Day


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


Contact us.