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

NCT06220357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-01-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Parintosa Atmodiwirjo, MD · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2023-10-10
Completion
2023-10-10

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06220357 on ClinicalTrials.gov