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The BREASTrial: Breast Reconstruction Evaluation of Acellular Dermal Matrix as a Sling Trial, Design and Stage I Outcomes of a Randomized Trial
Shaun D. Mendenhall, MD1, Layla A. Anderson, BA2, Jian Ying, PhD3, Kenneth M. Boucher, PhD3, Leigh A. Neumayer, MD, MS2, Jayant P. Agarwal, MD4.
1Southern Illinois University School of Medicine, Springfield, IL, USA, 2University of Utah School of Medicine, Department of Surgery, Salt Lake City, UT, USA, 3University of Utah School of Medicine, Division of Epidemiology and Biostatistics, Salt Lake City, UT, USA, 4University of Utah School of Medicine, Division of Plastic and Reconstructive Surgery, Salt Lake City, UT, USA.
Use of acellular dermal matrix (ADM) in tissue expander (TE) breast reconstruction has become a popular alternative to the total submuscular technique. Recent meta-analyses have demonstrated increased complication rates when ADM is used in breast reconstruction, however this data is retrospective and based predominantly on one type of ADM. The BREASTrial aims to prospectively compare the incidence and severity of complications in ADM breast reconstruction between two commonly used ADMs.
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, chemotherapy, mastectomy type, expander dynamics and drain time on complications and bio-integration of ADM was analyzed. The trial was divided into three different time periods/stages with the first stage results reported here. Logistic regression was utilized to determine predictors of complications.
128 patients (199 breasts) were equally randomized over 2.5-years (Figure 1). The majority of patients were white, healthy, non-smokers. During stage I, there was no difference in overall rates of complications (33.6% vs. 38.7%, p=0.52), infections (13.9% vs. 16.3%, p=0.64), seromas (6.1% vs. 3.1%, p=0.34), hematomas (0% vs. 2%, p=na), skin necrosis (17.8% vs. 20.4%, p=0.66), or expander loss (5.0% vs. 11.2%, p=0.11) between the AlloDerm and DermaMatrix groups respectively (Table 1). Complication grade was also similar (p=0.32). The AlloDerm group required less time to reach full expansion (42 vs. 70 days, p=0.001). No significant effect of obesity, radiation, or chemotherapy on incidence/severity of complications was detected. Obesity was a predictor of a longer need for drains (24% increase, p=0.02) and poor ADM bio-integration (OR 5.9, p=0.002) on multivariable logistic regression. Longer drain time also increased odds of complication incidence, severity, skin necrosis, and poor ADM bio-integration (OR 1.04, 1.04, 1.04, 1.05 respectively, p<0.04). Infection, skin necrosis, and poor ADM integration were all associated with tissue expander loss (p<0.001).
Stage I outcomes of the BREASTrial emphasize the importance of careful patient and allograft selection in ADM-based breast reconstruction. Different types of ADM may impact outcomes such as expander dynamics and should be studied further. Multiple regression analysis indicated that obesity was a predictor of poor ADM bio-integration and a longer need for drains, both which are associated with higher complication rates. Results from this trial will assist plastic surgeons in making evidence-based decisions regarding ADM-assisted breast reconstruction.
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