UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trial to monitor percutaneous oxygen saturation in autologous tissue transplantation
Title of the study (Brief title)	Trial to monitor percutaneous oxygen saturation in autologous tissue transplantation
Region	Japan

Condition
Condition	Autologous tissue transplantation
Classification by specialty	Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Free autologous tissue transplantation (musculoskeletal surgery) in the case of extensive skin soft tissue defect due to skin ulcer such as malignant tumor, trauma, decubitus ulcers or the like is possible to transplant tissue with blood flow by microsurgical microvascular anastomosis There is a reconstruction method that can obtain not only functionality but also tolerability. Conventionally, as postoperative management of musculoskeletal surgery, vision, pin prick test, confirmation of blood flow by doppler echo, etc. are performed, and in free jejunal transplantation surgery, monitoring intestinal tract preparation, observation of mucosal surface by endoscope, Periodic and intermittent monitoring and invasive monitoring such as observation of vascular stems by Doppler echo are performed, but in postoperative management by doctor alone it is sometimes difficult to respond promptly at the time of sudden change of state. Therefore, by digitizing postoperative state assessment using tissue oxygen saturation (blood flow evaluation), by allowing anyone to see it, including nurses, by early detection of rapid state change and countermeasure at an early stage , The purpose of this study was to avoid postoperative complications of flap necrosis due to blood vessel troubles.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Trend of changes in intraoperative and postoperative blood flow dynamics and tissue oxygen saturation.
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	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	A solution of 25 mg of indocyanine green in 10 ml of injection solution was intravenously administered 2 ml of indocyanine green solution per angiogram.
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	A case of reconstructive surgery performed with free tissue transplant with a vascular pattern (muscle flap or jejunal graft) in the Department of Plastic Surgery, Kochi University School of Medicine affiliated hospital for 6 years from 1 January 2011 to 31 December 2017.
Key exclusion criteria	Rebuilding surgery in the oral cavity and cases where the neck is short and the sensor can not be affixed after the jejunal transplantation do not undergo continuous surgical monitoring after surgery.
Target sample size	50

Research contact person
Name of lead principal investigator	Akiko Yano
Organization	Kouchi medical school
Division name	Surgery (Surgery 2)
Address	Kochi Prefecture Nankoku-shi Okou-cho Kohasu 185-1
TEL	0888802375
Email	y.akiko@kochi-u.ac.jp

Public contact
Name of contact person	Suzumi Oono
Organization	Kouchi medical school
Division name	Surgery (Surgery 2)
Address	Kochi Prefecture Nankoku-shi Okou-cho Kohasu 185-1
TEL	0888802375
Homepage URL
Email	im32@kochi-u.ac.jp

Sponsor
Institute	Kouchi medical school
Institute
Department

Funding Source
Organization	No
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	2016 Year 12 Month 09 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2011 Year 01 Month 01 Day
Anticipated trial start date	2011 Year 01 Month 01 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 09 Day
Last modified on	2016 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028985