Temperature Change, Body Clinical Trial
Official title:
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
Verified date | March 2024 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 63 |
Est. completion date | March 29, 2024 |
Est. primary completion date | March 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion | 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. | Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery | |
Secondary | The ICG fluorescence intensity in different titration dose with flap surface Temperature | 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 | Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery | |
Secondary | Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure | The transcutaneous carbon dioxide and oxygen pressure are shown in mmHg after being measured with transcutaneous (TCM) Combi 4 device. | Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery | |
Secondary | Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count | 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. | Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery | |
Secondary | Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume | 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. | Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery | |
Secondary | Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue | 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. | Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery | |
Secondary | Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha | 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. | Intraoperative (before start of anastomosis and before end of anastomosis time), 24 hours after surgery, 72 hours after surgery, 120 hours after surgery |
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