Cortiva Versus AlloDerm Ready-to-use in Prepectoral and Submuscular Breast Reconstruction: Prospective Randomized Clinical Trial Study Design and Early Findings

Abstract

Background:Several acellular dermal matrices (ADMs) can be used to provide soft-tissue support for post- and prepectoral prosthetic breast reconstructions. Yet, several recent meta-analysis suggest that due to a lack of rigorous evaluation in the setting of head-to-head prospective randomized control trials, few reliable conclusions regarding performance outcomes can be drawn. We compare Cortiva 1 mm to AlloDerm RTU in the setting of submuscular reconstruction in one study, and prepectoral in the second. Moreover, we present the findings from the interim analysis in our submuscular study.Methods:Using a single-blinded prospective randomized control trial design, we compare outcomes in 180 patients undergoing submuscular breast reconstruction with 16 × 8 cm ADM support (either Cortiva 1 mm or AlloDerm RTU). A parallel study evaluates 16 × 20 cm sheets of these ADMs in 180 patients undergoing prepectoral reconstructions. Time to drain removal, complications, fill volumes, patient-reported outcomes, and narcotic consumption are prospectively evaluated.Results:Interim analysis of 59 breasts in the submuscular study arm (Cortiva n = 31; AlloDerm n = 28) revealed no statistically significant differences with respect to outcome. At the time of interim analysis, the AlloDerm RTU group contained a higher proportion of never-smokers (P = 0.009), while patients implanted with Cortiva 1 mm received a larger tissue expander (P = 0.02).Conclusion:We present a protocol for a robust randomized control trial to evaluate outcomes in both submuscular and prepectoral prosthetic breast reconstruction assisted by 2 distinct types of ADM. Our interim analysis reveals no evidence of inferiority of outcomes in a comparison of AlloDerm to Cortiva.

Clinical Outcomes of Acellular Dermal Matrix (SimpliDerm and AlloDerm Ready-to-Use) in Immediate Breast Reconstruction

“…Importantly, the incidence of unplanned hADM explantation in this study was low (11.2%) with no difference between ADM type, and mirrors rates reported in the literature: a meta-analysis of 21 studies of ADM-assisted breast reconstructions reported ADM explanation rates ranging from 1.3% - 23.8% [ 20 ]. The most common individual complications in this study - infection (7.5%), flap ischemia (9.3%), and seroma (8.4%) - were also consistent with rates reported in published studies [ 2 - 8 , 12 , 19 , 20 ].…”

“…The total adverse event rate in our dataset was 25.2% - consistent with rates reported in the literature, which range from 3.9%-33.5% following ADM-based reconstructions [ 2 - 8 , 12 , 19 , 20 ]. Importantly, the incidence of unplanned hADM explantation in this study was low (11.2%) with no difference between ADM type, and mirrors rates reported in the literature: a meta-analysis of 21 studies of ADM-assisted breast reconstructions reported ADM explanation rates ranging from 1.3% - 23.8% [ 20 ].…”

“…The choice of hADM in each procedure was based on facility availability at the time of surgery for all physicians. As described in previous publications, the ADM was sutured to the inframammary fold and pectoralis major muscle [ 2 , 6 , 7 ]. Two drains were placed intraoperatively as previously described: one removed postoperatively after one week, and the other removed after output volume was less than 30 mL in a 24-hour period (normally performed at the two-week post-op visit in surgeons’ standard care) [ 16 ].…”

A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction

“…There are only two prospective randomized controlled trials involving ADMs in direct-to-implant subpectoral reconstruction [ 41 , 42 ]. Both involve Alloderm-RTU but none involve DermACELL.…”

“…Bard, Warwick, RI, USA) were not found to be statistically significant [ 41 ]. The second study compared Alloderm-RTU to another human-derived ADM called Cortiva 1 mm (RTI Surgical, Alachua, FL, USA) in a prospective randomized trial [ 42 ]. Although the trial is still ongoing, an interim analysis of 59 breasts in the subpectoral study arm revealed no statistically significant difference in terms of postoperative outcomes including drain duration of 17 days in both arms.…”