UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative monitoring of free flap by intraflap vascular catheterization and prevention of thrombosis.
Title of the study (Brief title)	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	Atsuomi Saiga
Organization	St Mary's Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	422, Tsubukuhonmachi, Kurume, Fukuoka, Japan
TEL	0942-35-3322
Email	s.atsuomi@gmail.com

Public contact
Name of contact person	Atsuomi Saiga
Organization	St Mary's Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	422, Tsubukuhonmachi, Kurume, Fukuoka, Japan
TEL	0942-35-3322
Homepage URL
Email	s.atsuomi@gmail.com

Sponsor
Institute	St Mary' s Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032037