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

NCT06220357 | Completed DMC

• 1 other identifier: 22-06-0636
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Free Flap Evaluation; Indocyanine Green Concentration; Perfusion

Keywords

Free flap; Indocyanine Green Reconstructive; Microsurgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group A (5 mg/mL)

EXPERIMENTAL

This group received 5 mg/mL of ICG or 100% in terms of concentration. The 1 mL of the ICG solution was taken using a 3 mL syringe

Diagnostic Test: Indocyanine Green

Group B (2,5 mg/mL)

ACTIVE COMPARATOR

This group received 2,5 mg/mL of ICG or 50% in terms of concentration. The 0.5 mL of the ICG solution was mixed with 0.5 mL of distilled water using a 1 cc syringe

Diagnostic Test: Indocyanine Green

Group C (0,5 mg/mL)

ACTIVE COMPARATOR

This group received 0,5 mg/mL of ICG or 10% in terms of concentration. The 0.1 mL of the ICG solution was mixed with 0.9 mL of distilled water using a 1 cc syringe

Diagnostic Test: Indocyanine Green

Interventions

Indocyanine Green DIAGNOSTIC_TEST

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.

Group A (5 mg/mL); Group B (2,5 mg/mL); Group C (0,5 mg/mL)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Officials

• Parintosa Atmodiwirjo, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: The population were divided into three equal groups of indocyanine green concentration : 5 mg/mL, 2,5 mg/mL, and 0,5 mg/mL

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: October 10, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)