UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006903 |
|---|---|
| Receipt number | R000008161 |
| Scientific Title | The efficacy of hyperbaric oxygenation therapy to crush injury:A randomized controlled clinical trial |
| Date of disclosure of the study information | 2011/12/26 |
| Last modified on | 2023/05/17 13:08:53 |
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Basic information
Public title
The efficacy of hyperbaric oxygenation therapy to crush injury:A randomized controlled clinical trial
Acronym
Hyperbaric oxygenation therapy to crush injury:A randomized controlled clinical trial
Scientific Title
The efficacy of hyperbaric oxygenation therapy to crush injury:A randomized controlled clinical trial
Scientific Title:Acronym
Hyperbaric oxygenation therapy to crush injury:A randomized controlled clinical trial
Region
| Japan |
Condition
Condition
Crush injury
Classification by specialty
| Orthopedics | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyzing effect of hyperbaric oxygenation therapy in the management of crush injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of infection, rate of re-operation
period in ICU, days until starting habilitation
days until discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
hyperbaric oxygenation therapy
Interventions/Control_2
Standerd thepapy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
crush injury and open fracture which severity more than Gustillo 3A and which area of injury are larger than 1 percent.
And match following condition
#No life threading injury in body trunk
#No claustrophobia
#Stabilized status in cardiac and respiratory status
Key exclusion criteria
Patients of unStabilized status in cardiac and respiratory status
Not match to Japanese clinical code for hyperbaric oxygenation therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki YAMADA |
Organization
Gifu University
Division name
Advanced critical care center
Zip code
Address
1-1 Yanagido Gifu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki YAMADA |
Organization
Gifu University
Division name
Advanced Critical Care Center
Zip code
Address
1-1 Yanagido Gifu
TEL
Homepage URL
hokken@go2.enjoy.ne.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 12 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008161
