UMIN-CTR Clinical Trial

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

Autologous tissue transplantation

Classification by specialty

Plastic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Trend of changes in intraoperative and postoperative blood flow dynamics and tissue oxygen saturation.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kouchi medical school

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

09

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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