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Plast Reconstr Surg Glob Open. 2018 Nov 13;6(11):e2013. doi: 10.1097/GOX.0000000000002013. eCollection 2018 Nov.

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

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Division of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.
Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.



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.


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.


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).


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.

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