UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027971 |
|---|---|
| Receipt number | R000032037 |
| Scientific Title | Postoperative monitoring of free flap by intraflap vascular catheterization and prevention of thrombosis. |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2017/06/28 15:03:38 |
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Basic information
Public title
Postoperative monitoring of free flap by intraflap vascular catheterization and prevention of thrombosis.
Acronym
Postoperative monitoring by IFVC
Scientific Title
Postoperative monitoring of free flap by intraflap vascular catheterization and prevention of thrombosis.
Scientific Title:Acronym
Postoperative monitoring by IFVC
Region
| Japan |
Condition
Condition
skin defect
Classification by specialty
| Plastic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of intra flap vascular catheterization in flap monitoring. At the same time, evaluate how this technique can prevent the thrombus formation after vascular anastomosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Reoperation rate
Key secondary outcomes
Flap survival rate
The number of urokinase injections in artery
The number of saline injections in vein
The change in postoperative arterial pressure and venous pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
At the time of free flap transfer, catheters are inserted in the artery and vein of the flap. Connect to pressure monitor and measure arterial pressure and venous pressure for 5 to 8 postoperative daysIf the arterial pressure falls below a certain pressure, flush the urokinase by 360 units. If the pressure does not rise even after repeating three times, consider reoperation as arterial thrombus formationFlush the physiological saline if the venous pressure rises above a certain pressure. If the pressure does not decrease even after repeating three times, think as a venous thrombosis and perform reoperation.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with skin defects and requiring reconstruction with free flap
Patient who got written consent for this study. In addition, if the age is under 20 years old, we also obtain written consent from the substitute
Key exclusion criteria
Ukinase contraindicated patients
Patients who failed to resume blood flow during surgery
Patient who could not insert catheter into flap
Patient who judged that whole body condition is bad.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuomi Saiga |
Organization
St Mary's Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
422, Tsubukuhonmachi, Kurume, Fukuoka, Japan
TEL
0942-35-3322
s.atsuomi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuomi Saiga |
Organization
St Mary's Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
422, Tsubukuhonmachi, Kurume, Fukuoka, Japan
TEL
0942-35-3322
Homepage URL
s.atsuomi@gmail.com
Sponsor or person
Institute
St Mary' s Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2017 | Year | 06 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032037
