UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027421 |
|---|---|
| Receipt number | R000031387 |
| Scientific Title | Investigate microbial dynamics of oral cancer patient by topical antibiotic administration to prophylactic infection after oral cancer surgery. |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/05/20 15:43:39 |
* 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
Investigate microbial dynamics of oral cancer patient by topical antibiotic administration to prophylactic infection after oral cancer surgery.
Acronym
Investigate microbial dynamics of oral cancer patient by topical antibiotic administration.
Scientific Title
Investigate microbial dynamics of oral cancer patient by topical antibiotic administration to prophylactic infection after oral cancer surgery.
Scientific Title:Acronym
Investigate microbial dynamics of oral cancer patient by topical antibiotic administration.
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of oral microbial dynamics in oropharyngeal fluid when coating tetracycline ointment on dorsum of tongue for the purpose of porophylaxis postponerative infection after oral cancer surgery.
Basic objectives2
Others
Basic objectives -Others
Confirmation of microbial dynamics in hypopharynx retention liquid.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation of oral microbial dynamics.
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Collection of oral reservoir
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. At the agreement acquisition, age is a patient younger than 90 years 20 years old or older
2. the patient whom conduct tracheostomy,neck dissection,ablation oral tumor,immediate reconstructive operation.
3. The patient whom I agreed with in response to enough explanation.
Key exclusion criteria
1.The patient that a state cannot clean the mouse badly from general condition.
2.The patient with a taboo and allergy for a drug.
3. The patient who judged that a study person in charge was inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuda Shoma |
Organization
Graduate School of Biomedical Sciences,Nagasaki University
Division name
Oral cancer treatment,Sciens Department,medical deployment
Zip code
Address
1-7-1 Sakamoto,Nagasaki City,Nagasaki Prefecture
TEL
095-819-7698
tsuda3@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuda Shoma |
Organization
Graduate School of Biomedical Sciences,Nagasaki University
Division name
Oral cancer treatment,Sciens Department,medical deployment
Zip code
Address
1-7-1 Sakamoto,Nagasaki City,Nagasaki Prefecture
TEL
095-819-7698
Homepage URL
tsuda3@nagasaki-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical Sciences,Nagasaki University.Oral cancer treatment,Sciens Department,medical deployment
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Biomedical Sciences,Nagasaki University.Oral cancer treatment,Sciens Department,medical deployment
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | 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
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 20 | Day |
Last modified on
| 2017 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031387
