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.

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

“…Although abundant data support the use of ADMs, 31–37 several recent meta-analyses confirm the need for additional level 1 and 2 evidence to establish how one ADM compares to another and how they are influenced by patient and therapeutic factors. There are a limited number of randomized control trials specifically comparing one ADM to another when providing support for submuscular reconstructions, 13,14,16 and none, in the context of prepectoral reconstructions.…”

“…This study, however, may have been underpowered as complications rates of 8% versus 26.1% were not found to be significantly different. 16 To our knowledge, there are no published RCTs comparing ADMs to one another when used in prepectoral breast reconstruction, an increasingly popular technique for prosthetic reconstruction Given the lack of high-quality studies available, a significant need remains for carefully designed and adequately powered RCTs comparing outcomes between various ADMs in submuscular and prepectoral prosthetic breast reconstruction.…”

Does the addition of mesh improve outcomes in implant based breast reconstruction after mastectomy for breast cancer?

“…Low quality evidence from three small trials comparing different types of mesh suggests no difference in outcomes 121314. Of these, one very low quality underpowered study14 reported a higher rate of implant loss and more postoperative pain, fatigue, and impact on family life with biological mesh compared with synthetic mesh.…”

“…An updated literature review has identified two small single centre randomised controlled trials comparing complications of different human acellular dermal matrixes1213 and shows no substantial differences in outcomes between different products (table 1). These studies were not reported in sufficient detail for the risk of bias to be formally assessed, but as the trials were largely explanatory, the results are unlikely to be generalisable.…”

Submuscular and Pre-pectoral ADM Assisted Immediate Breast Reconstruction: A Literature Review

“…Immediate breast reconstruction (IBR) received an important boost in popularity as a consequence of the advent of ADMs [ 2 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 ]. The use of ADMs showed encouraging results but conflicting reports as well [ 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 ]. ADMs-assisted breast reconstruction can be divided into pre-pectoral and submuscular.…”