UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effects of hyperbaric oxygen therapy on preventing surgical site infection in orofacial surgery
Acronym	A study on the effects of hyperbaric oxygen therapy on preventing surgical site infection in orofacial surgery
Scientific Title	A study on the effects of hyperbaric oxygen therapy on preventing surgical site infection in orofacial surgery
Scientific Title:Acronym	A study on the effects of hyperbaric oxygen therapy on preventing surgical site infection in orofacial surgery
Region	Japan

Condition
Condition	scheduled orofacial surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to propose appropriate concentration of inhaled oxygen in perioperative period of orofacial surgery by comparison of incidence of postoperative infection and side effects between 80% fraction of inhaled oxygen and 30% fraction of inhaled oxygen.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	surgical site infection
Key secondary outcomes	oxygen intoxication, CO2 narcosis, atelectasis and Paul Bert Effect (dizziness, headache, tinnitus, nausea and vomiting)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	80% oxygen inhalation during general anesthesia, 50% oxygen inhalation for 2 hours after surgery.
Interventions/Control_2	30% oxygen inhalation during general anesthesia and for 2 hours after surgery.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	scheduled orofacial surgery patient after informed consent is obtained, over 16 years old
Key exclusion criteria	the inability to give informed consent, under 16 years old Patients with a history of oxygen intoxication or lung diseases such as emphysema
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yuka Middle name Last name Oono
Organization	Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Division name	Division of Dental Anesthesiology
Zip code	350-0283
Address	1-1, Keyakidai, Sakado-shi, Saitama
TEL	049-279-2738
Email	yoono@dent.meikai.ac.jp

Public contact
Name of contact person	1st name Yuka Middle name Last name Oono
Organization	Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Division name	Division of Dental Anesthesiology
Zip code	350-0283
Address	1-1, Keyakidai, Sakado-shi, Saitama
TEL	049-279-2738
Homepage URL
Email	yoono@dent.meikai.ac.jp

Sponsor
Institute	Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Institute
Department

Funding Source
Organization	Meikai University School of Dentistry
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	Meikai University
Address	1-1, Keyakidai, Sakado-shi, Saitama
Tel	049-285-5511
Email	kenkyu@dent.meikai.ac.jp

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	2019 Year 02 Month 06 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	0
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	2017 Year 09 Month 15 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2019 Year 02 Month 12 Day
Last follow-up date	2022 Year 09 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 06 Day
Last modified on	2021 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040754