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Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multicenter, Prospective, Cohort Study

Venturi, Mark L. M.D.; Mesbahi, Ali N. M.D.; Boehmler, James H. IV M.D.; Marrogi, Aizen J. M.D.

Plastic and Reconstructive Surgery: January 2013 - Volume 131 - Issue 1 - p 9e–18e
doi: 10.1097/PRS.0b013e3182729d4f
Breast: Original Article

Background: Human acellular dermal matrices have gained increasing use in immediate expander-based breast reconstruction. However, some studies suggest that these grafts may be associated with a higher incidence of infection and seroma. To evaluate complication rates after matrix-based breast reconstruction, the authors conducted a prospective, multicenter, cohort study to evaluate a sterile human acellular dermal matrix in immediate expander-based breast reconstruction, specifically, to determine whether it offered a more favorable risk profile with respect to infection and seroma. A secondary purpose was to determine whether the sterilization process affects graft incorporation.

Methods: The authors performed 65 consecutive tissue expander-based breast reconstructions in a cohort of patients over a 1-year period using a single protocol. Sterile human matrix was used in all cases. The patients were evaluated for early complications (infection, seroma) and graft incorporation at the time of exchange or definitive reconstruction. Biopsies were performed in the first 20 reconstructions to provide histologic correlation of graft incorporation.

Results: Complications occurred in three breasts (4.6 percent), including one case of cellulitis (1.5 percent) and two cases of partial mastectomy flap necrosis (3.0 percent) that required débridement. There were no seromas or explantations. The grafts were incorporated in all cases and verified histologically in the first 20 biopsies.

Conclusions: Sterile human acellular dermal matrix can offer reliable matrix incorporation and a low complication rate. Sterilization does not negatively impact incorporation of the graft. The infection and seroma rates in this prospective study compare favorably to those in previous studies with nonsterilized (aseptic) acellular dermal matrix.

Washington, D.C.; Columbus, Ohio; and Silver Spring, Md.

From the Department of Plastic Surgery, Georgetown University Hospital; the Department of Plastic Surgery, Ohio State Medical Center; and the Department of Pathology and Area Laboratory Medicine, Walter Reed Army Medical Center.

Received for publication June 1, 2012; accepted July 3, 2012.

Presented at the Technology Innovation in Plastic Surgery Meeting, in San Francisco, California, on June 19, 2011.

This trial is registered under the name “Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study,” Clinical identification number NCT01372917 (

Disclosure: Dr. Venturi is a member of the speaker's bureau for Davol, Inc., and Allergan, Inc. Dr. Mesbahi is a member of the speaker's bureau for Davol, Inc. Neither of the other authors has any financial disclosures. This study was funded, in part, by an unrestricted research grant from Davol, Inc. (Warwick, R.I.).

Mark L. Venturi, M.D.; National Center for Plastic Surgery, 7601 Lewinsville Road, Suite 400, McLean, Va. 22102,

©2013American Society of Plastic Surgeons