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

N/ANot Yet RecruitingNCT07808957

Research Inc300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

300

Conditions

Soft Tissue Filler Complication

Interventions

Indocyanine GreenDRUG

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 AssessmentPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From surgery through postoperative day 30. 30 days

Secondary Outcomes

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.

Time frame: From surgery through postoperative day 30. 30 days

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 frame: From surgery through postoperative day 30. 30days

Time to Complete Wound Healing

Number of days from surgery to complete epithelialization without drainage or dressing requirement, censored at 90 days.

Time frame: From surgery through postoperative day 90. 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.

Time frame: From indocyanine green administration through 24 hours after surgery. 1 day

Incidence of Reoperation for Wound Complications

Proportion of participants requiring operative debridement, revision closure, grafting, or flap reconstruction for a wound complication.