An interventional study of Indocyanine Green and Standard Clinical Perfusion Assessment in Soft Tissue Filler Complication, Surgical Flap Ischemia and Tissue Necrosis, sponsored by Research Inc. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · Not applicable, Interventional, and Prevention
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.
545 studies on the registry are indexed under Ischemia; 72 are open to participants now.
This study's planned enrollment of 300 is above the median of 74 across 356 interventional studies indexed under Ischemia.
Browse Ischemia studies →Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard clinical assessment plus intraoperative indocyanine green fluorescence angiography. Hypoperfused regions may prompt additional excision, release of tension, or modification of closure according to the locked decision algorithm.
Drug: Indocyanine Green · Procedure: Standard Clinical Perfusion Assessment
Flap perfusion is assessed using routine clinical criteria without fluorescence imaging. All other perioperative care follows the same institutional protocol.
Procedure: Standard Clinical Perfusion Assessment
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.
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
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.
Time frame: From surgery through postoperative day 90. 90 days
Plan to share: No — not considered in the patient consent form
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 82 interventional studies with no phase under Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 48. This study's planned 2 months is below that.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indocyanine Green