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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.

Author information

1
Division of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.
2
Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.

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.

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