UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000799 |
|---|---|
| Receipt number | R000000942 |
| Scientific Title | Preoperative detection of skin perforators by indocyanine green fluorescence near infrared angiography |
| Date of disclosure of the study information | 2007/08/10 |
| Last modified on | 2007/08/10 15:50:04 |
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Basic information
Public title
Preoperative detection of skin perforators by indocyanine green fluorescence near infrared angiography
Acronym
Preoperative detection of skin perforators by ICG angiography
Scientific Title
Preoperative detection of skin perforators by indocyanine green fluorescence near infrared angiography
Scientific Title:Acronym
Preoperative detection of skin perforators by ICG angiography
Region
| Japan |
Condition
Condition
Skin defects following surgical excision or trauma that require reconstruction by perforator-based flap surgery
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prediction of the location of the perforators is required for perforator-based flap surgery. In this study, we evaluate the utility of ICG angiography for identifying skin perforators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Intraoperative confirmation of being perforators deteced preoperatively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients who requier perforator-based flap surgey will have preoperative ICG angiography. Based on the angiography, surgical planning including choice of the location of flap harvesting and the mean of flap mobilization will be made.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requiering perforator-based flap surgery
Key exclusion criteria
Patients having medical history of allergic reactions to Indocyanine green or iodine.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Azuma |
Organization
National Defense Medical College
Division name
Plastic Surgery
Zip code
Address
3-2 Namiki Tokorozawa city Saitama pref.
TEL
04-2995-1511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Azuma |
Organization
National Defense Medical College
Division name
Plastic Surgery
Zip code
Address
3-2 Namiki Tokorozawa city Saitama pref.
TEL
04-2995-1511
Homepage URL
azuma@ri.ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2007 | Year | 08 | Month | 10 | 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
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 10 | Day |
Last modified on
| 2007 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000942
