UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038640 |
|---|---|
| Receipt number | R000044029 |
| Scientific Title | Preventive therapy of ishcemic flap necrosis by topical application of angiogenic factors |
| Date of disclosure of the study information | 2019/11/19 |
| Last modified on | 2022/05/23 11:23:39 |
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Basic information
Public title
Preventive therapy of ishcemic flap necrosis by topical application of angiogenic factors
Acronym
Topical angiogenic factors for ishcemic flap necrosis
Scientific Title
Preventive therapy of ishcemic flap necrosis by topical application of angiogenic factors
Scientific Title:Acronym
Topical angiogenic factors for ishcemic flap necrosis
Region
| Japan |
Condition
Condition
Ischemic flap necrosis
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Rescue of flap necrosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surviving zone in the flap
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Topical application of angiogenic factors
Interventions/Control_2
No treatment
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
After flap operation
Key exclusion criteria
Malignancy
Pregnancy
Minimal operation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Mashiko |
Organization
Toranomon Hospital
Division name
Plastic surgery
Zip code
105-8470
Address
Minatok-Ku 2-2-2, Tokyo, Japan
TEL
09072260121
aesthetic_qp@hotmail.com
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Mashiko |
Organization
Toranomon Hospital
Division name
Plastic surgery
Zip code
105-8470
Address
Minatok-Ku 2-2-2, Tokyo, Japan
TEL
09072260121
Homepage URL
aesthetic_qp@hotmail.com
Sponsor or person
Institute
Federation of National Public Service Personnel Mutual Aid Associations, Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Federation of National Public Service Personnel Mutual Aid Associations, Toranomon Hospital
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
IRB of Toranomon hospital
Address
Minatok-Ku 2-2-2, Tokyo, Japan
Tel
03-3588-1111
chiken-jim@toranomon.gr.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 | 11 | Month | 19 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
10
Results
Effective but low number of subjects.
Results date posted
| 2022 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
After flap surgeries.
Participant flow
Prospective.
Adverse events
No events.
Outcome measures
Survival rate of flaps.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044029
| 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 |
