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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06313385
Other study ID # 22-10-1180
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date March 29, 2024

Study information

Verified date March 2024
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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.

Study Design


Intervention

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
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.
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
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
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.

Locations

Country Name City State
Indonesia Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia Jakarta Pusat Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

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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