Prospective Observational Study of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix in Implant-Based Breast Reconstruction

Background: Conventional detergent-based decellularization can disrupt extracellular matrix (ECM) structure and denature proteins. Supercritical carbon dioxide (scCO₂) processing offers a simplified manufacturing process (<2 h), minimal protein denaturation, and excellent ECM preservation. This study aimed to evaluate the clinical outcomes of scCO2 processing acellular dermal matrix (ADM) compared with conventional detergent-processed ADM. Methods: This prospective observational study enrolled patients undergoing immediate implant-based breast reconstruction with scCO₂-processed ADM (n = 50) and compared outcomes with a retrospective cohort receiving conventional detergent-processed human ADM (n = 50). Patient demographics, comorbidities, and treatment variables were collected. Postoperative complications and BREAST-Q–assessed patient-reported outcomes were analyzed. Results: The groups were comparable in age (45.0 ± 10.4 vs. 46.8 ± 9.4 years, p = 0.362), body mass index (BMI; median 21.5 vs. 22.7 kg/m², p = 0.558), comorbidities, and oncologic characteristics. Rates of skin necrosis (2% vs. 0%), nipple-areolar complex (NAC) necrosis (2% vs. 2%), hematoma (4% vs. 4%), seroma (6% vs. 0%), infection (6% vs. 0%), capsular contracture (8% vs. 12%), implant failure (0% vs. 0%), implant change (2% vs. 2%), and reoperation (2% vs. 2%) did not differ significantly between groups. BREAST-Q questionnaires revealed no significant differences in patient-reported outcomes. Conclusions: scCO₂-processed ADM demonstrated safety and patient-reported outcomes equivalent to established detergent-based ADMs. Given its eco-friendly, protein-preserving manufacturing process, scCO₂-processed ADM represents a safe and effective alternative for implant-based breast reconstruction. Long-term follow-up studies are warranted.