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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018318
Receipt No. R000021202
Scientific Title Multicenter study of oral management for prevention of surgical site infection in oral cancer surgery
Date of disclosure of the study information 2015/08/01
Last modified on 2017/05/20

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Basic information
Public title Multicenter study of oral management for prevention of surgical site infection in oral cancer surgery
Acronym Oral management for prevention of SSI in oral cancer surgery
Scientific Title Multicenter study of oral management for prevention of surgical site infection in oral cancer surgery
Scientific Title:Acronym 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
1st name
Middle name
Last name Madoka Funahara
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Clinical Oral Oncology
Zip code
Address 1-7-1, Sakamoto,Nagasaki
TEL 095-819-7698
Email madoca@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Madoka Funahara
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Clinical Oral Oncology
Zip code
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)

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
2015 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 Completed
Date of protocol fixation
2014 Year 08 Month 12 Day
Date of IRB
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

Other
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

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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