Soft Tissue Filler Complication, Surgical Flap Ischemia, Tissue Necrosis
Conditions
Keywords
Indocyanine Green, Fluorescence Angiography, Perfusion Imaging, Gluteal Flap, Wound Dehiscence, Tissue Necrosis, Biopolymers
Brief 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.
Detailed description
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.
Interventions
DRUGIndocyanine 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.
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.
Sponsors
Research Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ischemic Gluteal Flap Complications | From surgery through postoperative day 30. 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Partial- or Full-Thickness Flap Necrosis | From surgery through postoperative day 30. 30 days | Proportion of participants with adjudicated tissue necrosis, reported separately as partial- and full-thickness and by surface area category. |
| Intraoperative Change in Surgical Management | From surgery through postoperative day 30. 30days | 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 | From surgery through postoperative day 90. 90 days | Number of days from surgery to complete epithelialization without drainage or dressing requirement, censored at 90 days. |
| Incidence of Indocyanine Green-Related Adverse Reactions | From indocyanine green administration through 24 hours after surgery. 1 day | Proportion of intervention participants with hypersensitivity, urticaria, hemodynamic reaction, bronchospasm, or other adverse event judged related to indocyanine green. |
| Incidence of Reoperation for Wound Complications | From surgery through postoperative day 90. 90 days | Proportion of participants requiring operative debridement, revision closure, grafting, or flap reconstruction for a wound complication. |
Countries
Colombia
Contacts
CONTACTEdison Osorio, MD, Plastic surgeon
PRINCIPAL_INVESTIGATOREdison Osorio, MD, plastic surgery
Bioforma clinic
Outcome results
None listed