Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal

Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal

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.

Adults undergoing gluteal filler-removal surgery with flap elevation will be randomized before definitive flap assessment. In both groups, the surgeon will record the planned closure after routine clinical evaluation. In the intervention group, intravenous indocyanine green and a standardized near-infrared imaging protocol will then be used to identify hypoperfused tissue. Management changes will follow a locked decision algorithm. The control group will proceed using clinical assessment alone. Postoperative wounds will be evaluated by assessors masked to allocation using standardized definitions and photographs through day 90. The trial will compare the 30-day composite ischemic complication rate and will evaluate necrosis, dehiscence, reoperation, time to healing, ICG-related reactions, and quantitative perfusion metrics.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Prior enrollment in this trial for a contralateral or repeat operation.
• Inability to undergo standardized postoperative wound assessment.