The BREASTrial Stage III: Acellular Dermal Matrix Breast Reconstruction Outcomes from Three Months to Two Years Postoperative

Abstract

Background:The Breast Reconstruction Evaluation of Acellular Dermal Matrix as a Sling Trial (BREASTrial) is a blinded, randomized trial comparing the outcomes of tissue expander breast reconstruction using AlloDerm or DermaMatrix. In this final stage of the trial, outcomes 3 months to 2 years after definitive reconstruction are reported along with patient satisfaction data. Methods: A randomized trial was conducted to compare complication rates between groups of patients who underwent reconstruction with AlloDerm and DermaMatrix. Regression models were used to analyze the impact of matrix type, age, chemotherapy, radiation therapy, and reconstructive type on complication rates. Premastectomy and postmastectomy questionnaires were used to assess patient satisfaction and were also analyzed using regression models. Results: Of the 128 patients (199 breasts) who were randomized in the trial, 108 patients (167 breasts) were available for analysis in stage III. There was no difference in the overall complication rates between the AlloDerm and DermaMatrix groups (6% versus 13.2%; P = 0.3) or the severity of those complications (P = 0.7). Obesity was a positive predictor for complications, regardless of reconstruction group (P = 0.02). Patient satisfaction was positive overall and did not grossly vary between AlloDerm and DermaMatrix groups. Conclusions: Findings from the BREASTrial conclude that AlloDerm and DermaMatrix exhibit similar histologic and clinical outcomes. Patient satisfaction is also similar between matrices. Obesity is a predictor of complications, and acellular dermal matrices should be used with caution in these patients. As the largest head-to-head trial comparing two acellular dermal matrices, the BREASTrial contributes to the fund of knowledge regarding acellular dermal matrix supplementation in breast reconstruction.

Comparison of 30-day Clinical Outcomes with SimpliDerm and AlloDerm RTU in Immediate Breast Reconstruction

“…AlloDerm has been used to support postmastectomy breast reconstruction for more than a decade and has demonstrated comparable clinical outcomes to other ADMs, with similar complication types and rates. 4,10,[18][19][20][21][22][23][24] The results of this preliminary study describe similar initial (30-day) SimpliDerm is derived from donated human dermis, which is gently processed using patented methods for decellularization and antigen removal before hydration and subsequent sterilization. The processing steps for SimpliDerm were designed to ensure low antigenicity and high sterility, while minimizing crosslinking and other alterations to ECM, thereby preserving the ECM microstructure and bioactive factors of native dermis.…”

“…The reported comparable complication rates and handling characteristics of ADMs used for breast reconstruction suggest an opportunity to improve performance through optimized product design. 9,10 SimpliDerm (Aziyo Biologics, Silver Spring, Md.) is a new human ADM (hADM) product manufactured using patented processes designed to better preserve the characteristics of native tissue, such as the extracellular matrix (ECM) and the biologically active mediators embedded therein.…”

Impact of Chemotherapy and Radiation Therapy on Inflammatory Response, Neovascularization, and Capsule Formation of Acellular Dermal Matrix in Breast Reconstruction: Analysis of the BREASTrial Biopsy Specimens

“…Despite randomizing patients in a blinded fashion, the group of patients who underwent reconstruction with DermaMatrix contained more smokers and contained more patients who received adjuvant therapy. 1,2,27 With this consideration, the group who underwent reconstruction with DermaMatrix exhibited the greatest reduction of lymphocytes under the presence of chemotherapy and radiation therapy. This reduction in lymphocytes may provide added benefits by enhancing wound healing, as inflammation negatively influences granulation tissue deposition and wound healing.…”

“…The trial was divided into three outcome stages for ease of analysis and reporting. Stages I and II were previously reported, 1,2 and stage III is in press. This study, as part of the BREASTrial, explored the histologic impact of adjuvant therapy on the outcomes of two acellular dermal matrix types through measuring inflammation, neovascularization, and capsule formation.…”

No Differences in Surgical and Patient-reported Outcomes Between Alloderm, Surgimend, and Dermacell for Prepectoral Implant-based Breast Reconstruction

“…10 Although these three ADMs differ in their origins, processing, and characteristics, they all share the acellular matrix structure, which allows for incorporation and integration into the host tissue through cellular infiltration and revascularization. 10–12…”