UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter study of oral management for prevention of surgical site infection in oral cancer surgery
Title of the study (Brief title)	Oral management for prevention of SSI in 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	Occurrence rate of SSI
Key secondary outcomes	Occurrence rate of postoperative pneumonia

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Maneuver
Interventions/Control_1	Effect of topical administration of tetracycline ointment to prevention of surgical site infection in oral cancer surgery with flap reconstruction
Interventions/Control_2	Conventional oral care
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 Flap reconstruction Tracheotomy
Key exclusion criteria	IC not obtained
Target sample size	150

Research contact person
Name of lead principal investigator	Madoka Funahara
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Clinical Oral Oncology
Address	1-7-1, Sakamoto,Nagasaki
TEL	095-819-7698
Email	madoca@nagasaki-u.ac.jp

Public contact
Name of contact person	Madoka Funahara
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Clinical Oral Oncology
Address	1-7-1, Sakamoto,Nagasaki
TEL	095-819-7698
Homepage URL
Email	madoca@nagasaki-u.ac.jp

Sponsor
Institute	Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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)

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	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 12 Day
Anticipated trial start date	2015 Year 08 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	2015 Year 07 Month 15 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=R000021202