The BREASTrial Stage II: ADM Breast Reconstruction Outcomes from the Time of Implant Exchange to 3 Months Post-Op

Background:  The BREASTrial is a prospective randomized trial comparing outcomes of tissue expander breast reconstruction using either AlloDerm or DermaMatrix.  The trial was divided into three outcome stages: stage I) from the time of mastectomy and tissue expander placement until implant exchange, stage II) from implant exchange until 3 months post-op, and stage III) 3 months post-op until 2 years status-post definitive implant placement (Figure 1).  Stage I outcomes have been previously reported.  The present study reports stage II outcomes. 

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).  Complication rates were compared between groups utilizing the Mann-Whitney U test.  The impact of matrix type, age, obesity, radiation, chemotherapy, and recon type on complications was analyzed via a univariate logistic regression model.

Results:  Of the 128 patients (199 breasts) who were randomized in the trial, 108 patients (173 breasts) were available for analysis in stage II (Figure 1).  The majority of patients were white, healthy, non-smokers.  During stage II, there was no difference in overall rates of complications (11.0% vs. 12.2%, p=0.4), infections (3.3% vs. 6.1%, p=0.2), seromas (0% vs. 0%, p=NA), hematomas (1.1% vs. 0%, p=0.2), skin necrosis (2.2% vs. 2.4%, p=0.5), or implant loss (2.2% vs. 2.4%, p=0.5) between the AlloDerm and DermaMatrix groups respectively (Table 1).  Obesity was the only significant predictor of complications on univariate regression analysis (OR 4.31, p= 0.007).  No significant effect of matrix, age, radiation, chemotherapy, or recon type (autologous vs. implant) on incidence/severity of complications was detected.

Conclusions:  The BREASTrial is the largest prospective randomized trial to date in ADM breast reconstruction. Results from Stage II demonstrate the need for careful patient selection in ADM breast reconstruction. Regression analysis indicated that obesity was associated with complications which raises concern for ADM use in this population.  The trial also revealed that autologous reconstruction after ADM-assisted tissue expansion does not lead to more complications than implant-based reconstruction.  Results from the BREASTrial will assist plastic surgeons in making evidence-based decisions regarding ADM-assisted breast reconstruction.