Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: A prospective randomized trial

Abstract

AlloDerm RTU® and AlloMaxTM are two acellular dermal matrices (ADMs) used in implant-based breast reconstruction. In this study, we examined whether different processing methods for the ADMs lead to a disparity in histologic, clinical, and financial outcomes after breast reconstruction. Thirty patients undergoing implant-based breast reconstruction were randomized into AlloMax or AlloDerm arms (n=15, each). ADM was placed at the time of immediate reconstruction. Patients were evaluated for complications on postoperative days 7, 14, and 30. During implant exchange, ADM biopsies were taken and compared histologically for vascular and cellular infiltration. Patient satisfaction was evaluated using the BRECON-31 questionnaire 1 year after implant exchange. A cost analysis was performed comparing the two ADMs. Patient demographics and complication rates were similar between the two groups (p>0.05). Histologically, vessel density and fibroblast/inflammatory cell infiltrate were greater on the dermal side than on the implant side (p<0.01) in both ADMs, suggesting greater vascular and cellular in-growth from the dermal side. Vessel density in the middle portion of the Allomax biopsies was significantly higher than the same site in the Alloderm biopsies (p<0.05). The extent of fibroblast/inflammatory cell infiltration was similar in both arms (p>0.05). The BRECON-31 satisfaction questionnaire yielded similar responses across all metrics between the two study arms. The negotiated price was slightly different when comparing the two ADMs, with no significant difference in ADM reimbursement. In this study, AlloDerm RTU and AlloMax were successfully used for implant-based breast reconstruction with comparable outcomes.