Abstract: The BREASTrial: Breast Reconstruction Evaluation of Acellular Dermal Matrix As a Sling Trial, Design and Early Outcomes of a Randomized Trial (Plastic Surgery 2013)

Saturday, October 12, 2013: 2:05 PM

Shaun D Mendenhall, MD , Institute for Plastic Surgery, Southern Illinois University School of Medicine, Springfield, IL

Layla A Anderson, BA , Dept. of Surgery, University of Utah, SALT LAKE CITY, UT

Jian Ying, PhD , Division of Epidemiology, University of Utah School of Medicine, SALT LAKE CITY, UT

Ting Liu, MD , Dept. of Pathology, University of Utah, SALT LAKE CITY, UT

Kenneth M. Boucher, PhD , Division of Epidemiology, University of Utah School of Medicine, Salt Lake City, UT

Leigh A Neumayer, MD, MS , Dept. of Surgery, University of Utah, SALT LAKE CITY, UT

Jayant P Agarwal, MD , Division of Plastic Surgery, University of Utah School of Medicine, SALT LAKE CITY, UT

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Background: Use of acellular dermal matrix (ADM) in tissue expander (TE) breast reconstruction has become a popular adjunct to the total submuscular technique. The risks and benefits of its use have recently been questioned. However, the majority of data available on the topic are from low level-of-evidence studies leaving many questions incompletely answered. Furthermore, head-to-head comparisons of different ADMs are sparse. The BREASTrial aims to prospectively compare the incidence and severity of complications in ADM breast reconstruction between two commonly used ADMs.

Methods: After IRB approval, a randomized trial was conducted to compare outcomes of immediate TE breast reconstruction using either AlloDerm (Lifecell) or DermaMatrix (Synthes) (clinicaltrials.gov identifier: NCT00872859). The impact of obesity, radiation, and chemotherapy on complications and bio-integration of ADM was analyzed. The trial was divided into three different time periods/stages (Figure) with the first stage results reported here.

Results: 128 patients (199 breasts) were equally randomized over 2.5-years (Figure). The majority of patients were white, healthy, non-smokers. During stage I, there was no difference in overall rates of complications (33.6% vs. 37.8%, p=0.6), infections (13.9% vs. 16.3%, p=0.29), seromas (6.1% vs. 3.1%, p=0.34), hematomas (0% vs. 2%, p=na), or skin necrosis (17.8% vs. 20.4%, p=0.66) between the AlloDerm and DermaMatrix groups respectively (Table). Complication severity was also similar (p=0.41). The AlloDerm group required significantly less time to reach full expansion (43 vs. 71 days, p=0.001). No significant effect of obesity, radiation, or chemotherapy on incidence and severity of complications was detected. Obesity correlated with poor ADM bio-integration (OR 7.1, 95%CI 2.8-17.7, p<0.001) and a longer need for drains (27% increase, p=0.01). Longer time before drain removal also correlated with higher complication rate and severity, and worse ADM bio-integration (OR 1.04, 1.05, 1.05 respectively, p<0.01).

Conclusions: The BREASTrial is the largest prospective randomized trial to date in ADM breast reconstruction. Results from Stage I demonstrate the need for careful patient selection in ADM breast reconstruction. Results from this study indicate that obesity was correlated with an increased odds of poor ADM bio-integration and a longer need for drains. The trial also shows that different ADMs can impact expansion dynamics such as length of time until complete expansion. Results from the BREASTrial will assist plastic surgeons in making evidence-based decisions regarding ADM-assisted breast reconstruction.

22633 The BREASTrial: Breast Reconstruction Evaluation of Acellular Dermal Matrix As a Sling Trial, Design and Early Outcomes of a Randomized Trial