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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027421
Receipt No. 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

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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
Last 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
Email tsuda3@nagasaki-u.ac.jp

Public contact
1st 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
Email tsuda3@nagasaki-u.ac.jp

Sponsor
Institute Graduate School of Biomedical Sciences,Nagasaki University.Oral cancer treatment,Sciens Department,medical deployment
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031387

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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