Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators

Indonesia University63 enrolled

Overview

This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses.

The ICG contrast solution will be evaluated with Near-Infrared (NIR) camera that being fixated 20 cm above the flap after the injection. The imaging result will be analyzed using ImageJ Application to assess the grey value. The fluorescent intensity of ICG will be compared with other tests. Drop Out Criteria : * Patients who are unable to complete the research procedure due to various condition, such as death * Patients who experience complications or worsening, during and after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

Conditions

Free Flap Indocyanine Green Microsurgery

Interventions

Indocyanine Green Fluorescence (ICG)DIAGNOSTIC_TEST

The ICG will be injected intravenously and being assessed with Near-infrared (NIR) camera FLUORO4000XL 20 cm above the flap and fluorescence intensity counted with application called ImageJ

TemperatureDIAGNOSTIC_TEST

Portable thermal imaging camera called Forward-looking infrared (FLIR) ONE® was used to assess flap and normal skin temperature. The FLIR ONE® device was place in perpendicular manner from the skin. The images were attained in two points of times which is direct temperature and after cold challenge test.

Transcutaneous oxygen and carbon dioxide pressureDIAGNOSTIC_TEST

The partial transcutaneous pressure is measured in flap using transcutaneous monitor (TCM) Combi probe. The probe should be cleaned using alcohol pads before use. After 5-10 minutes, the TCM 4 machine monitor should show stable transcutaneous oxygen and carbon dioxide pressure from the flap

HistopathologyDIAGNOSTIC_TEST

A part of tissue from free flap is acquired and stored in 10% formalin tube. Later on, the tissue was colored with hematoxylin-eosin, neutrophile count, necrosis volume, and vessel proliferation will be assessed

Hypoxia inducible factor-1 (HIF-1) alphaDIAGNOSTIC_TEST

Peripheral tissue from distal free flap (0,5 x 0,5 cm in size) is obtained and stored in tube with dry ice. The tissue is assessed with human HIF - 1 Alpha Enzyme-Linked Immunosorbent Assay (ELISA) kit ab171577.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Free flap operation that being performed by researchers. * Free Flap must have a skin paddle located on the body skin area with intraoperative ischemic time of at least 60 Minutes * Free flap should be in a viable/vital condition judged from the clinical examination of the flap, which includes color, temperature, turgor, capillary refill time (CRT), and skin prick test, immediately post surgery * Body area that will be a flap-free donor area has no history of trauma or operation * Patient with blood albumin value \>3 gr / dL * The patient/family sign the informed consent sheet stating willingness to become research sample Exclusion Criteria: * Patients have increased sensitivity to iodine or ICG * Free Flaps that being transported undergo trauma or damage due to external factors during treatment * Patient with high urea and creatinine level * Patient with high Alanine transaminase (ALT) and Aspartate transaminase (AST) level * Patients who receive injectable heparin treatment containing natrium disulfite preoperatively * Patients who regularly take anti-seizure drugs, haloperidol, heroin, meperidine, Metamizole, methadone, morphine, nitrofurantoin, opium, phenobarbital, and phenylbutazone.

Outcomes

Primary Outcomes

The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion

The fluorescence of ICG that being captured with near-infrared (NIR) camera is store in video file to be evaluated. The video duration is 2 minutes long after ICG injection. The fluorescence intensity of the flap in the video is being measured with ImageJ application. The highest level of intensity (numerical data) is considered as the optimal fluorescence intensity that being analyzed later on. The optimal indocyanine green titration will be seen after ImageJ analysis in numerical data called gray values.