NCT06313385

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

The Effect of Indocyanine Green Titration on Fluorescent Intensity Degree in Free Flap : A Lookout to Flap Surface Temperature, TCPO2, TCPCO2, HIF-1 Alpha Expression Level, and Histopathology

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-03-29
• Completion: 2024-03-29
• First posted: 2024-03-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: Indonesia