UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044932 |
|---|---|
| Receipt number | R000051265 |
| Scientific Title | An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/07/21 14:35:31 |
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Basic information
Public title
An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Acronym
An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Scientific Title
An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Scientific Title:Acronym
An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Region
| Japan |
Condition
Condition
Oral Cancer
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
consider to Whether comprehensive oral care, including antibiotics on the tongue, is effective in reducing oropharyngeal bacteria (tongue, saliva, and intratracheal invaders) and preventing postoperative complications.
Basic objectives2
Others
Basic objectives -Others
consider to Whether comprehensive oral care, including antibiotics on the tongue, is effective in reducing oropharyngeal bacteria (tongue, saliva, and intratracheal invaders) and preventing postoperative complications.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effective in reducing oropharyngeal bacteria (tongue, saliva, and intratracheal invaders)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of cetylpyridinium chloride spray
Interventions/Control_2
Untreated 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1Patients who are planning surgery using flaps.
2Patients who undergo surgery under general anesthesia and require a hospital stay of 7 days or more after surgery.
3Patients who agreed to participate in this study.
Key exclusion criteria
1Patients who are judged by the principal investigator to be inappropriate for participation in this research.
2 Patients who are allergic to the drug used.
3 Patients with a high possibility that swallowing function will be significantly impaired (subtotal tongue resection or total tongue resection surgery, etc.)
Scheduled patient).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kurita |
Organization
Shinshu university School of Medicine
Division name
Dentistry and Oral Surgery
Zip code
0900802
Address
Asahi 3-1-1, Matsumoto
TEL
0263-37-2677
hkurita@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kurita |
Organization
Shinshu university School of Medicine
Division name
Dentistry and Oral Surgery
Zip code
3900802
Address
Asahi 3-1-1, Matsumoto
TEL
0263-37-2677
Homepage URL
hkurita@shinshu-u.ac.jp
Sponsor or person
Institute
Dept.of Dentistry and Oral Surgery,Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sunstar
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu university School of Medicine
Address
Asahi 3-1-1, Matsumoto
Tel
0263-37-2677
shinshu-u.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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2021 | Year | 07 | Month | 21 | Day |
Last modified on
| 2021 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051265
