Cortiva vs AlloDerm in Prepectoral and Partial Submuscular Implant-Based Breast Reconstruction: A Randomized Clinical Trial.

BACKGROUND: Several acellular dermal matrices (ADMs) are utilized for soft tissue support in prosthetic breast reconstruction. Little high-level evidence supports the use of one ADM over another. Therefore, we sought to compare Cortiva 1mm Allograft Dermis to AlloDerm RTU, the most studied ADM in the literature. METHODS: A single-blinded randomized controlled trial comparing Cortiva to AlloDerm in prepectoral and subpectoral immediate prosthetic breast reconstruction was performed at two academic hospitals from March 2017 to December 2021. Reconstructions were direct-to-implant (DTI) or tissue expander (TE). Primary outcome was reconstructive failure, defined as TE explantation prior to planned further reconstruction, or explantation of DTI reconstructions before 3 months postoperatively. Secondary outcomes were additional complications, patient-reported outcomes (PROs), and cost. RESULTS: There were 302 patients included - 151 AlloDerm (280 breasts), 151 Cortiva (277 breasts). Reconstructions in both cohorts were majority TE (62% vs 38% DTI), smooth device (68% vs 32% textured), and prepectoral (80% vs 20% subpectoral). Reconstructive failure was no different between ADMs (AlloDerm 9.3% vs Cortiva 8.3%, p=0.68). There were no additional differences in any complications or PROs between ADMs. Seromas occurred in 7.6% of Cortiva but 12 % of AlloDerm cases, whose odds of seroma formation were two-fold (OR 1.93, 95% CI 1.01-3.67, p=0.047) higher. AlloDerm variable cost was 10-15% more than Cortiva, and there were no additional cost differences. CONCLUSION: When assessing safety, clinical performance, PROs, and cost, Cortiva is non-inferior to AlloDerm in immediate prosthetic breast reconstruction and may be cheaper with lower risk of seroma formation.