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

Summary

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.

Conditions

• Free Flap
• Indocyanine Green
• Microsurgery
• Temperature Change, Body

Interventions

DIAGNOSTIC_TEST

Indocyanine Green Fluorescence (ICG)

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

DIAGNOSTIC_TEST

Temperature

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.

DIAGNOSTIC_TEST

Transcutaneous oxygen and carbon dioxide pressure

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

DIAGNOSTIC_TEST

Histopathology

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

DIAGNOSTIC_TEST

Hypoxia inducible factor-1 (HIF-1) alpha

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.

Sponsors & Collaborators

• Indonesia University

  lead OTHER

Principal Investigators

• Parintosa Atmodiwirjo · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2024-03-29

Completion

2024-03-29

Countries

• Indonesia

Study Locations