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.
Age 18 to 65 years.
Scheduled for elective gluteal permanent synthetic filler removal with flap elevation and primary closure.
Expected availability of the study fluorescence imaging system.
Ability to provide written informed consent and complete 90-day wound follow-up.
Known hypersensitivity to indocyanine green.
Pregnancy or breastfeeding.
Emergency surgery, uncontrolled sepsis, or hemodynamic instability at the time of randomization.
Severe hepatic dysfunction or another condition judged by anesthesia to make indocyanine green inappropriate.
Parallel
Indocyanine Green
DrugPROPOSED 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
Procedure/SurgerySurgeon 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.
Incidence of Ischemic Gluteal Flap Complications
Proportion of participants with at least one adjudicated event: clinically significant flap ischemia requiring treatment, ischemia-related wound dehiscence, partial-thickness necrosis, or full-thickness necrosis. A masked committee will apply prespecified definitions using clinical records and standardized photographs.
Incidence of Partial- or Full-Thickness Flap Necrosis
Proportion of participants with adjudicated tissue necrosis, reported separately as partial- and full-thickness and by surface area category.
Intraoperative Change in Surgical Management
Proportion of intervention participants in whom ICG imaging causes additional tissue excision, release of closure tension, change in flap design, delay in closure, or another documented management modification compared with the plan recorded immediately before imaging.
Time to Complete Wound Healing
Number of days from surgery to complete epithelialization without drainage or dressing requirement, censored at 90 days.
Incidence of Indocyanine Green-Related Adverse Reactions
Proportion of intervention participants with hypersensitivity, urticaria, hemodynamic reaction, bronchospasm, or other adverse event judged related to indocyanine green.
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