Diluted Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery

Perfusion Clinical Trial

Official title:

Comparing Diluted to Standard Concentration Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06220357
• Other study ID #: 22-06-0636
• Status: Completed
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: January 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Perfusion

Intervention

Diagnostic Test:
• Indocyanine Green
The patients were split into three different groups, the patient were given ICG with three different concentrations in a double-blind randomized manner postoperatively. The fluorescence emitted was quantitatively analyzed using the ImageJ software to ascertain the mean gray values, providing a robust measure of the ICGA concentration. The imaging was captured using a FLUORO 4000XL type NIR camera, positioned at a distance of 15-20 cm perpendicular to the flap.

Locations

Country	Name	City	State
Indonesia	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	Gray value of indocyanine green fluorescent	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.	2-5 minutes after the ICG injection