Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators
- Conditions
- Free FlapMicrosurgeryTemperature Change, BodyIndocyanine Green
- Interventions
- Diagnostic Test: Indocyanine Green Fluorescence (ICG)Diagnostic Test: TemperatureDiagnostic Test: Transcutaneous oxygen and carbon dioxide pressureDiagnostic Test: HistopathologyDiagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha
- Registration Number
- NCT06313385
- Lead Sponsor
- Indonesia University
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 63
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 5 mg/mL Indocyanine Green Fluorescence (ICG) 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. Group 5 mg/mL Transcutaneous oxygen and carbon dioxide pressure 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. Group 5 mg/mL Histopathology 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. Group 0,5 mg/mL Histopathology 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%. Group 2,5 mg/mL Transcutaneous oxygen and carbon dioxide pressure 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%. Group 0,5 mg/mL Transcutaneous oxygen and carbon dioxide pressure 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%. Group 5 mg/mL Temperature 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. Group 2,5 mg/mL Indocyanine Green Fluorescence (ICG) 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%. Group 2,5 mg/mL Hypoxia inducible factor-1 (HIF-1) alpha 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%. Group 2,5 mg/mL Histopathology 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%. Group 5 mg/mL Hypoxia inducible factor-1 (HIF-1) alpha 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. Group 2,5 mg/mL Temperature 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%. Group 0,5 mg/mL Indocyanine Green Fluorescence (ICG) 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%. Group 0,5 mg/mL Temperature 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%. Group 0,5 mg/mL Hypoxia inducible factor-1 (HIF-1) alpha 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%.
- Primary Outcome Measures
Name Time Method The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery 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.
- Secondary Outcome Measures
Name Time Method Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery The necrosis volume result is shown in numerical data percentage (%). High power field which is 20x optical view magnification in microscope. This is part of histopathology examination.
Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery The transcutaneous carbon dioxide and oxygen pressure are shown in mmHg after being measured with transcutaneous (TCM) Combi 4 device.
The ICG fluorescence intensity in different titration dose with flap surface Temperature Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery The surface temperature of the flap and the surrounding normal tissue is being measured with mobile thermal camera. The temperature result is shown in celsius degree
Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery The neutrophile count is shown as cells per high power field. The high power field in this study is 20x optical view magnification in microscope. This is part of histopathology examination.
Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery The vascular flap proliferation can be seen using after the tissue sample is stained immunohistochemically using cluster of differentiation (CD) 31 marker in 20x optical view magnification using microscope. The result will be seen in numerical data. This is part of histopathology examination.
Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha Intraoperative (before start of anastomosis and before end of anastomosis time), 24 hours after surgery, 72 hours after surgery, 120 hours after surgery The ICG fluorescence intensity in 3 different titration dose will be compared with HIF-1 Alpha. The HIF-1 Alpha will be shown as numerical value in ng/mg of proteins.
Trial Locations
- Locations (1)
Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia
🇮🇩Jakarta Pusat, Jakarta, Indonesia