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

NAActive, not recruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

March 29, 2024

Study Completion Date

March 29, 2024

Conditions
Free FlapIndocyanine GreenMicrosurgeryTemperature 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.

Trial Locations (1)

10430

Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta Pusat

All Listed Sponsors
lead

Indonesia University

OTHER