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

University of Indonesia (UI)

Status: Active, not recruiting

Conditions: Microsurgery; Indocyanine Green; Temperature Change, Body; Free Flap

Treatments: Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure; Diagnostic Test: Histopathology; Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha; Diagnostic Test: Temperature; Diagnostic Test: Indocyanine Green Fluorescence (ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06313385

22-10-1180

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups

Group 5 mg/mL

Experimental group

Description:

This group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package.

Treatment:

Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha

Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure

Diagnostic Test: Indocyanine Green Fluorescence (ICG)

Diagnostic Test: Histopathology

Diagnostic Test: Temperature

Group 2,5 mg/mL

Active Comparator group

Description:

This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%.

Treatment:

Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha

Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure

Diagnostic Test: Indocyanine Green Fluorescence (ICG)

Diagnostic Test: Histopathology

Diagnostic Test: Temperature

Group 0,5 mg/mL

Active Comparator group

Description:

This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%.

Treatment:

Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha

Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure

Diagnostic Test: Indocyanine Green Fluorescence (ICG)

Diagnostic Test: Histopathology

Diagnostic Test: Temperature