Status:
COMPLETED
Diluted Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery
Lead Sponsor:
Indonesia University
Conditions:
Free Flap Evaluation
Indocyanine Green Concentration
Eligibility:
All Genders
Phase:
NA
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...
Detailed 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06220357
Start Date
October 10 2022
End Date
October 10 2023
Last Update
January 23 2024
Active Locations (1)
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1
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430