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

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.

Timeline

Start

2026-10-01

Primary completion

2026-12-01

Completion

2027-10-01

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.