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

Area of Science:

• Oncology
• Biomaterials Science
• Plastic Surgery

Background:

• Breast cancer is a leading global cancer in women.
• Breast-conserving surgery (BCS) aims for tissue removal and breast preservation.
• Oncoplastic techniques and biomaterials enhance BCS outcomes.

Purpose of the Study:

• To evaluate REGENERA™, a novel biomaterial scaffold, for volume replacement in BCS.
• To assess the safety, efficacy, and patient-reported outcomes of REGENERA™ in a multicentric trial.
• To present preliminary data on REGENERA™ use in breast reconstruction.

Main Methods:

• A multicentric trial involving 16 patients undergoing BCS with REGENERA™ implantation.
• Data collection included adverse events, cosmetic outcomes, imaging interference, pain (VAS), and quality of life (BREAST-Q).
• Follow-up averaged 3 months across three European centers.

Main Results:

• No device-related complications or allergies were reported.
• Three seromas (18.75%) were observed, necessitating drain use.
• Significant improvement in the BREAST-Q Psychosocial Well-Being Chest score (23 to 52.33) at 1 month.

Conclusions:

• REGENERA™ shows potential as a biomaterial for breast volume replacement in BCS.
• The scaffold demonstrated high patient satisfaction and a favorable safety profile.
• Long-term studies are required to fully ascertain REGENERA™'s efficacy and safety.