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

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

Stakeholders’ Perspectives on Postmastectomy Breast Reconstruction: Recognizing Ways to Improve Shared Decision Making

Background:. Postmastectomy breast reconstruction (PMBR) is an elective, preference-sensitive decision made during a stressful, time-pressured period after a cancer diagnosis. Shared decision making (SDM) can improve decision quality about preference-sensitive choices. Stakeholders’ perspectives on ways to support PMBR decision-making were explored. Methods:. Forty semi-structured interviews with stakeholders (20 postmastectomy patients, 10 PMBR surgeons, 10 PMBR nurses) were conducted. Clinicians were recruited from diverse practices across the United States. Patients were recruited using purposive sampling with varying PMBR experiences, including no reconstruction. The interview guide was based on an implementation research framework. Themes were identified using grounded theory approach, based on frequency and emotive force conveyed. Results:. Engagement in SDM was variable. Some patients wanted more information about PMBR from clinicians, particularly about risks. Some clinicians acknowledged highlighting benefits and downplaying risks. Many patients felt pressured to make a choice by their clinicians. Clinicians who successfully engaged patients through decisions often used outside resources to supplement conversations. Conclusions:. Patient–clinician trust was critical to high-quality decisions, and many patients expressed decision regret when they were not engaged in PMBR discussions. Patients often perceived a race- or age-related bias in clinician information sharing. Interventions to support SDM may enhance decision quality and reduce decision regret about PMBR, ultimately improving patient-centered care for women with breast cancer