Comparing Diluted to Standard Concentration Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Gray value of indocyanine green fluorescent
研究概览
简要总结
The evaluation of perfusion in free flaps is crucial in clinical practice. Currently, the gold standard for evaluation is subjective through clinical assessment. However, indocyanine green angiography (ICGA), a tool that uses a near-infrared (NIR) camera to depict and monitor flap vascularization, offers an objective and reproducible alternative. The population in this study were divided into three equal groups, where each groups were assessed with Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). The study was conducted with three distinct concentrations of ICGA: 5 mg/mL (100% standard concentration), 2.5 mg/mL (50%), and 0.5 mg/mL (10%). Indocyanine green was given in immediate postoperative manner, after the patient defect has been reconstructed with free flap.
详细描述
Indocyanine green (ICG) angiography is a novel technique for assessing tissue perfusion. The primary outcome is gray values that being evaluated with IMAGE. Through this study optimal concentration that will show fluorescence in NIR camera can be seen. This is important in order to evaluate free flap perfusion.
This study included 47 patients who underwent free flap surgery. The subjects were consisted of postoperative patient with fibular free flap (FFF), anterolateral thigh flap (ALT), radial forearm free flap (RFFF), and deep inferior epigastric perforator flap (DIEP), with inclusion criteria of this study are individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The indocyanine green (ICG) is added into the syringe by research assistant before operation ended. Each bottle contains 25 mg of lipophilic powder with the active ingredient being ICG. It is packaged with 5 ml of sterile distilled water for dilution, resulting in a solution of 5 mg/ml. The dilution process was carried out carefully to ensure the accuracy of the concentrations. The ICG was diluted into several concentrations using sterile distilled water. The patient didn't know which concentration were given to them. The injection to the patient was performed by anesthesiologist who didn't know about the concentration
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery. Furthermore, these subjects exhibit an albumin level exceeding 3 g/dL, Haemoglobin more than 10mg/dL, and no complication intraoperative
排除标准
- •patients with a history of allergy or hypersensitivity to iodine or ICG, those with renal insufficiency or undergoing routine hemodialysis, and those regularly consuming sodium bisulfites. Additionally, patients with hepatic dysfunction, those regularly taking anticonvulsant drugs, and those experiencing complications during and post-operation are also excluded. Furthermore, patients with psychopathology and/or mental disorders, and those whose transferred free flap has experienced trauma or damage due to external factors during care are not suitable for this study
结局指标
主要结局
Gray value of indocyanine green fluorescent
时间窗: 2-5 minutes after the ICG injection
The gray values were seen as the primary outcome to found which concentration has the best fluorescence outcome. NIR Camera, 20 cm above the flap, will assess the fluorescence due to contrast. All groups results are being evaluated with IMAGEJ to produce gray value.
次要结局
未报告次要终点
研究者
Parintosa Atmodiwirjo
Medical Doctor
Indonesia University