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Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal
Sponsor: Research Inc
Summary
This randomized clinical trial will compare indocyanine green fluorescence angiography-guided assessment with standard clinical assessment of gluteal flap perfusion during removal of permanent synthetic fillers. Participants will be assigned 1:1 to fluorescence-guided or standard management. The primary outcome is the occurrence of flap ischemia, ischemia-related wound dehiscence, or tissue necrosis through postoperative day 30. Dye-related adverse reactions, management changes, wound healing, infection, and reoperation will also be evaluated.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-10-01
Completion Date
2027-10-01
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Indocyanine Green
PROPOSED regimen: 0.05 mg/kg intravenously followed by a saline flush after flap preparation and before definitive closure; one repeat dose may be used if the image is technically inadequate, within the approved local labeling and maximum dose. Final product, concentration, and dose must be confirmed. Linked arm/group(s): ICG-Guided Perfusion Assessment.
Standard Clinical Perfusion Assessment
Surgeon assessment based on tissue color, capillary refill, dermal bleeding, temperature, and clinical judgment. This procedure is used in both groups; the control group does not receive fluorescence imaging. Linked arm/group(s): ICG-Guided Perfusion Assessment, Standard Clinical Perfusion Assessment.
Locations (1)
Clinica Bioforma
Medellín, Colombia