UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigate microbial dynamics of oral cancer patient by topical antibiotic administration to prophylactic infection after oral cancer surgery.
Title of the study (Brief title)	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	Tsuda Shoma
Organization	Graduate School of Biomedical Sciences,Nagasaki University
Division name	Oral cancer treatment,Sciens Department,medical deployment
Address	1-7-1 Sakamoto,Nagasaki City,Nagasaki Prefecture
TEL	095-819-7698
Email	tsuda3@nagasaki-u.ac.jp

Public contact
Name of contact person	Tsuda Shoma
Organization	Graduate School of Biomedical Sciences,Nagasaki University
Division name	Oral cancer treatment,Sciens Department,medical deployment
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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