Clinical trial NCT06313385: Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Free Flap
Indocyanine Green
Microsurgery
Temperature Change, Body
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The population were divided into three equal groups of indocyanine green concentration : 5 milligram per milliliter (mg/mL), 2,5 mg/mL, and 0,5 mg/mL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion
timeFrame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Secondary outcomes:
measure: The ICG fluorescence intensity in different titration dose with flap surface Temperature
timeFrame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
measure: Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure
timeFrame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count
timeFrame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume
timeFrame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
measure: Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue
timeFrame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
measure: Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha
timeFrame: Intraoperative (before start of anastomosis and before end of anastomosis time), 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia
state: Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Parintosa Atmodiwirjo
role: PRINCIPAL_INVESTIGATOR
References: