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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035786
Receipt No. R000040754
Scientific Title A study on the effects of hyperbaric oxygen therapy on preventing surgical site infection in orofacial surgery
Date of disclosure of the study information 2019/02/06
Last modified on 2019/03/30

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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
Last 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
1st 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
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 Enrolling by invitation
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
2019 Year 03 Month 30 Day


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

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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