UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025197 |
|---|---|
| Receipt number | 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 12:21:28 |
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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
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
im32@kochi-u.ac.jp
Sponsor or person
Institute
Kouchi medical school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028985
