UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031105 |
|---|---|
| Receipt number | R000035473 |
| Scientific Title | An evaluation of skin viability using fingerstall-type tissue oximetry |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2020/03/11 09:21:14 |
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Basic information
Public title
An evaluation of skin viability using fingerstall-type tissue oximetry
Acronym
Evaluation of skin viability using fingerstall-type tissue oximetry
Scientific Title
An evaluation of skin viability using fingerstall-type tissue oximetry
Scientific Title:Acronym
Evaluation of skin viability using fingerstall-type tissue oximetry
Region
| Japan |
Condition
Condition
Skin flap (free and pedicle), Ischemic limb
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To get regional tissue oxygen saturation and total hemoglobin index in the reconstructive surgery with skin flaps and ischemic limb surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Regional tissue oxygen saturation and total hemoglobin index
Key secondary outcomes
Skin tissue ischemia and related complications a month after the operation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Assessment of regional saturation of oxygen and total hemoglobin index in the skin by the finger-mounted near-infrared spectroscopy
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
free and pedicle flap, limb ischemia
Key exclusion criteria
Unsuited patients for investigation such as severe infection and shock
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIdekazu Fukamizu |
Organization
Hamamatsu University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
Address
1-20-1 Handayama higashi-ku Hamamatsu, Japan
TEL
053-435-2155
fukamizu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIdekazu Fukamizu |
Organization
Hamamatsu University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
Address
1-20-1 Handayama higashi-ku Hamamatsu, Japan
TEL
053-435-2155
Homepage URL
fukamizu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
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
浜松医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035473
