UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051551 |
|---|---|
| Receipt number | R000058819 |
| Scientific Title | Effect of hyperbaric oxygen therapy on skin flap and graft-analysis by near-infrared time-resolved spectroscopy |
| Date of disclosure of the study information | 2023/07/25 |
| Last modified on | 2024/01/09 16:10:05 |
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Basic information
Public title
Effect of hyperbaric oxygen therapy on skin flap and graft-analysis by near-infrared time-resolved spectroscopy
Acronym
Objective effect of hyperbaric oxygen therapy on skin flap and graft
Scientific Title
Effect of hyperbaric oxygen therapy on skin flap and graft-analysis by near-infrared time-resolved spectroscopy
Scientific Title:Acronym
Objective effect of hyperbaric oxygen therapy on skin flap and graft
Region
| Japan |
Condition
Condition
skin flap and skin graft
Classification by specialty
| Anesthesiology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the changes in tissue oxygenation and tissue hemoglobin concentration measured by near-infrared time-resolved spectroscope before and after the hyperbaric oxygen therapy on skin flap and graft.
To observe chronological changes of these indices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute changes in tissue oxygenation and tissue hemoglobin concentration measured by near-infrared time-resolved spectroscope before and after the hyperbaric oxygen therapy on skin flap and graft
Key secondary outcomes
chronological changes of tissue oxygenation and tissue hemoglobin concentration in continuing of hyperbaric oxygen therapy.
Evaluation of factors which may affect the effect of hyperbaric oxygen therapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
The patients who consent to this study after the sufficient explanation
Key exclusion criteria
The patients whom a research director judges to be inappropriate as a study subject
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morimoto |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
0608648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Morimoto |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
0608648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
morim2@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
Hokkaido University Hospital Division of Clinical Research Administraion
Address
N14 W5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2023 | Year | 07 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Study period:until 2025.12.31
Patients with skin flap or skin graft
Observational items:background, laboratory data, vital signs and tissue oxygenation and hemoglobin concentration
Management information
Registered date
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058819
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
