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

NCT07808957 | Not Yet Recruiting

• 1 other identifier: 010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Filler Complication; Surgical Flap Ischemia; Tissue Necrosis

Keywords

Indocyanine Green; Fluorescence Angiography; Perfusion Imaging; Gluteal Flap; Wound Dehiscence; Tissue Necrosis; Biopolymers

Outcome Measures

Primary Outcomes (1)

• 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.

  From surgery through postoperative day 30. 30 days

Secondary Outcomes (5)

• Incidence of Partial- or Full-Thickness Flap Necrosis

  From surgery through postoperative day 30. 30 days

• Intraoperative Change in Surgical Management

  From surgery through postoperative day 30. 30days

• Time to Complete Wound Healing

  From surgery through postoperative day 90. 90 days

• Incidence of Indocyanine Green-Related Adverse Reactions

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

• Incidence of Reoperation for Wound Complications

  From surgery through postoperative day 90. 90 days

Study Arms (2)

ICG-Guided Perfusion Assessment (Experimental)

EXPERIMENTAL

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

Standard Clinical Perfusion Assessment (Active Comparator)

ACTIVE COMPARATOR

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

Interventions

Indocyanine Green DRUG

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.

ICG-Guided Perfusion Assessment (Experimental)

Standard Clinical Perfusion Assessment PROCEDURE

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.

ICG-Guided Perfusion Assessment (Experimental); Standard Clinical Perfusion Assessment (Active Comparator)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

Clinica Bioforma

Medellín, Colombia

Location

Related Publications (5)

• Patel NK, Henderson J, Uygur HS. Lateral Intercostal Artery Perforator Flap for Axillary Breast Reconstruction in a Previously Irradiated and Dissected Field. Indian J Plast Surg. 2026 Apr 15;59(3):232-236. doi: 10.1055/s-0046-1817012. eCollection 2026 Jun.

  PMID: 42592441 BACKGROUND

• Aleman R, Carrasquilla A, Rodriguez-Zentner H, Lanzarini E, Sinagra D, Rancati A, Marinelli F, Ghiselli J, Gorreri MA, Aleman J, Dip F. Fluorescence-guided surgery in Latin America: A multinational survey of adoption, barriers, and collaboration. Surgery. 2026 Jul 21:110452. doi: 10.1016/j.surg.2026.110452. Online ahead of print.

  PMID: 42608249 BACKGROUND

• Zhu Z, Hajek B, Jin Y, Stojanovski S, Jankulovska A, Angjushev D, Djikovski I, Jakupi N, Colanceski R, Ferati I, Antevski B, Vela I, Despotovski D, Tolevska Dimitrovska N, Bogdanovska Todorovska M, Kondov G, Kondov B, Nie S, Singhal S, Gruev V. A single-chip, dual-gain color-NIR camera for fluorescence-guided lung and breast cancer surgery. Light Sci Appl. 2026 Aug 21;15(1):359. doi: 10.1038/s41377-026-02437-9.

  PMID: 42629355 BACKGROUND

• Moreno-Llorente P, Ruiz M, Garcia-Barrasa A, Recasens-Subias M, Larranaga I, Carnaval T, Videla S. Cost-effectiveness of angiography-guided thyroidectomy to prevent postoperative hypoparathyroidism: Spanish National Health System model-based analysis. BJS Open. 2026 Jul 3;10(4):zrag095. doi: 10.1093/bjsopen/zrag095.

  PMID: 42485666 BACKGROUND

• Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.

  PMID: 42495057 BACKGROUND

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Edison Osorio, MD, plastic surgery

  Bioforma clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edison Osorio, MD, Plastic surgeon

CONTACT

+573226140611; info@edisonosorio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)