UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035786 |
|---|---|
| Receipt number | 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 | 2021/02/07 15:01:10 |
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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
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
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
yoono@dent.meikai.ac.jp
Sponsor or person
Institute
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040754
