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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025197
Receipt No. R000028985
Scientific Title Trial to monitor percutaneous oxygen saturation in autologous tissue transplantation
Date of disclosure of the study information 2016/12/09
Last modified on 2016/12/09

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Basic information
Public title Trial to monitor percutaneous oxygen saturation in autologous tissue transplantation
Acronym Trial to monitor percutaneous oxygen saturation in autologous tissue transplantation
Scientific Title Trial to monitor percutaneous oxygen saturation in autologous tissue transplantation
Scientific Title:Acronym 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
1st name
Middle name
Last name Akiko Yano
Organization Kouchi medical school
Division name Surgery (Surgery 2)
Zip code
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
1st name
Middle name
Last name Suzumi Oono
Organization Kouchi medical school
Division name Surgery (Surgery 2)
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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