UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035571 |
|---|---|
| Receipt number | R000040529 |
| Scientific Title | Gargles and oral bacteria number association with various mouthwash to the patient after oral cancer surgery |
| Date of disclosure of the study information | 2019/01/17 |
| Last modified on | 2024/04/30 09:21:19 |
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Basic information
Public title
Gargles and oral bacteria number association with various mouthwash to the patient after oral cancer surgery
Acronym
Gargles and oral bacteria number association with various mouthwash to the patient after oral cancer surgery
Scientific Title
Gargles and oral bacteria number association with various mouthwash to the patient after oral cancer surgery
Scientific Title:Acronym
Gargles and oral bacteria number association with various mouthwash to the patient after oral cancer surgery
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prevention of SSI in oral cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of bacteria after gargling
Key secondary outcomes
Gargle effect duration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
After oral cancer surgery without reconstruction, gargle with iodine gargle and measure the change in the number of bacteria
Interventions/Control_2
Conventional rinsing with water as a control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Oral cancer surgery without flap reconstruction
Key exclusion criteria
IC not obtained
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyushu Dental University School of Oral Health Sciences
Division name
Unit of education on healthcare team
Zip code
803-8580
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, 803-8580, Japan
TEL
093-285-3109
macloca02@gmail.com
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyushu Dental University School of Oral Health Sciences
Division name
Unit of education on healthcare team
Zip code
803-8580
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, 803-8580, Japan
TEL
093-285-3109
Homepage URL
macloca02@gmail.com
Sponsor or person
Institute
Unit of education on healthcare team,
Kyushu Dental University School of Oral Health Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Review Committee, Kyushu Dental University
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan
Tel
093-285-3011
gakusei@kyu-dent.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
| 2019 | Year | 01 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040529
