Volume replacement procedure adopting biomaterial: early considerations from a multicentric study.

Abstract

Breast cancer remains the most prevalent female cancer, affecting 2.3 million women worldwide in 2022 (WHO). Breast-conserving surgery aims to remove cancerous tissue while preserving the breast, often incorporating oncoplastic techniques for better cosmetic outcomes. The use of biomaterials for volume replacement, such as the REGENERA^™ biomimetic polyurethane-based patented scaffold, could make these procedures less invasive, with faster recovery and shorter operative times. This article presents preliminary data from a multicentric trial exploring the use of REGENERA^™ in breast reconstruction after breast-conserving surgery. This study included patients operated from 14^th June 2023 to 15^th May 2024. The involved centers are: Breast Surgery Unit, Santa Chiara Hospital, Pisa (Italy, ITA01), European Institute of Oncology, Milan (Italy, ITA02), and Hospital A Coruña, A Coruña (Spain, ESP01). For each patient, we evaluated the incidence of adverse events, changes in breast appearance (using photographs and anthropomorphic measurements), interference with ultrasounds and MRI, investigator's satisfaction, patient's pain (through VAS scale), and quality of life (using BREAST-Q questionnaire). Our early experience included 16 patients meeting the inclusion/exclusion criteria from the 3 centers (3 patients from ESP01, 7 from ITA01, and 6 from ITA02). No complications or allergies related to the device were observed, with a mean follow-up of 3 months. The only complication observed was 3 seromas accounting for 18.75% of patients, justifying the use of drains when REGENERA^™ is used. BREAST-Q questionnaire results at 1-month follow-up showed no statistical significant improvements except for the Psychosocial Well-Being Chest section, which moved from a pre-operative score of 23 to a post-operative score of 52.33. The REGENERA^™ scaffold shows promise as a novel biomaterial for volume replacement in breast-conserving surgery, with high patient satisfaction and minimal complications. Further research and long-term follow-up are necessary to fully evaluate its efficacy and safety. Trial registration: ClinicalTrials.gov (NCT05941299).