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

Conventional detergent-based decellularization can disrupt the extracellular matrix (ECM) structure and denature proteins. Supercritical carbon dioxide (scCO ₂ ) processing offers a simplified manufacturing process (<2 hours), minimal protein denaturation, and excellent ECM preservation. This study aimed to evaluate the clinical outcomes of scCO ₂ processing acellular dermal matrix (ADM) compared with conventional detergent-processed ADM.

This prospective observational study enrolled patients undergoing immediate implant-based breast reconstruction with scCO ₂ -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.

The groups were comparable in age (45.0 ± 10.4 years vs. 46.8 ± 9.4 years, p  = 0.362), body mass index (median: 21.5 kg/m ² vs. 22.7 kg/m ² , p  = 0.558), comorbidities, and oncologic characteristics. Rates of skin necrosis (2% vs. 0%), nipple-areolar complex 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.

scCO ₂ -processed ADM demonstrated safety and patient-reported outcomes equivalent to established detergent-based ADMs. Given its eco-friendly, protein-preserving manufacturing process, scCO ₂ -processed ADM represents a safe and effective alternative for implant-based breast reconstruction. Long-term follow-up studies are warranted.