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The BREASTrial: Stage I. Outcomes from the Time of Tissue Expander and Acellular Dermal Matrix Placement to Definitive Reconstruction

Mendenhall, Shaun D. M.D.; Anderson, Layla A. B.A.; Ying, Jian Ph.D.; Boucher, Kenneth M. Ph.D.; Liu, Ting M.D.; Neumayer, Leigh A. M.D., M.S.; Agarwal, Jayant P. M.D.

Plastic and Reconstructive Surgery: January 2015 - Volume 135 - Issue 1 - p 29e–42e
doi: 10.1097/PRS.0000000000000758
Breast: Original Articles
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Background: Use of acellular dermal matrix in tissue expander breast reconstruction has become a popular adjunct to the total submuscular technique. The question remains as to which matrix, if any, is ideal for breast reconstruction.

Methods: A randomized trial was conducted to analyze outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of obesity, radiation, and chemotherapy on complications and biointegration of matrix was investigated. The trial was divided into three stages, with stage I results reported here.

Results: One hundred twenty-eight patients (199 breasts) were randomized equally over 2.5 years. Most patients were white, healthy nonsmokers. The overall complication rate was 36.2 percent; half of the complications were minor. The AlloDerm and DermaMatrix groups had similar rates of complications (33.6 percent versus 38.8 percent; p = 0.52), consisting mostly of skin necrosis (17.8 percent versus 21.4 percent; p = 0.66) and infections (13.9 percent versus 16.3 percent; p = 0.29), both of which led to tissue expander losses (5 percent versus 11.2 percent; p = 0.11). The AlloDerm group required less time for completion of expansion (42 days versus 70 days; p < 0.001). Obesity was associated with poor matrix biointegration and a longer drain time, both of which were associated with higher complication rates.

Conclusion: The Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial is the largest randomized trial to date in matrix breast reconstruction and emphasizes the importance of careful patient and allograft selection to minimize complications.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Salt Lake City, Utah; and Springfield, Ill.

From the Division of Plastic and Reconstructive Surgery, the Department of Surgery, the Division of Epidemiology, Department of Internal Medicine, and the Department of Pathology, University of Utah School of Medicine; and the Institute for Plastic Surgery, Southern Illinois University School of Medicine.

Received for publication December 7, 2013; accepted May 28, 2014.

This trial is registered under the name “The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial,” ClinicalTrials.gov identification number NCT00872859 (http://clinicaltrials.gov/ct2/show/study/NCT00872859).

Presented at the 82nd Annual Meeting of the American Society of Plastic Surgeons, in San Diego, California, October 11 through 15, 2013; and at the 59th Annual Meeting of the Plastic Surgery Research Council, New York, New York, March 7 through 9, 2014.

Disclosure: This is an investigator-initiated study funded by grants from the University of Utah, Lifecell, and Synthes. The authors have no other financial conflicts of interest to disclose related to the contents of this article.

Jayant P. Agarwal, M.D., Division of Plastic and Reconstructive Surgery, University of Utah School of Medicine, 30 North 1900 East, 3B400, Salt Lake City, Utah 84132, jay.agarwal@hsc.utah.edu

©2015American Society of Plastic Surgeons