Aseptic Freeze Dried vs. Sterile Wet-Packaged Human Cadaveric Acellular Dermal Matrix (ADM) in Immediate Tissue Expander Breast Reconstruction: A Propensity Score Analysis Study

Background: Although multiple acellular dermal matrix (ADM) sources exist, it is unclear how ADM processing impacts complication rates. We compared complications between two preparations of human cadaveric ADM (freeze dried [hADM-FD] and ready to use [hADM-RTU]) in immediate tissue expander (TE) breast reconstruction to analyze the effect of processing on complications. HADM-FD is aseptic while hADM-RTU is sterilized and wet-packaged. Methods: We retrospectively reviewed all TE breast reconstructions with hADM-FD or hADM-RTU at a single center between 2006 and 2016. The primary outcome measure was surgical site occurrence (SSO) before implant placement. SSO was defined as: seroma, skin dehiscence, surgical site infection (SSI), or reconstructive failure. The hADM-FD and hADM-RTU groups were compared before and after propensity-score (PS) matching. Results: We included 988 TE reconstructions (53.8% hADM-FD vs. 46.2% hADM-RTU). Analysis of 384 PS-pairs demonstrated a slightly higher rate of SSO (21.4% vs. 16.7%, p=0.10) and SSI (9.6% vs. 7.8%, p=0.13) in the hADM-FD group than hADM-RTU, but the difference was not significant. However, reconstructive failure was significantly higher for hADM-FD versus hADM-RTU (7.8% vs. 4.4%, p=0.050). Conclusions: This is the largest study comparing the outcomes of TE breast reconstruction using hADM materials prepared by different methods. We demonstrated higher early complications with aseptic hADM-FD than sterile hADM-RTU; reconstructive failure was the only outcome to achieve statistical significance. Additionally, there were significantly higher late complications with hADM-RTU compared to hADM-FD. We conclude that ADM preparation has an independent impact on patient outcomes in our comparison of one company's product. Financial Disclosure: Dr. Selber is a consultant for Integra Life Sciences (Plainsboro, NJ). Dr. Hassid is a consultant for Novadaq Technologies, Inc (Bonita Springs, FL). No other author has any disclosures related to this article. Financial Support: This research was supported in part by an Investigator Initiated Research Grant from LifeCell Corporation (Branchburg, NJ). Products mentioned: Alloderm Freeze Dried (LifeCell Corporation, Branchburg, NJ); Alloderm Ready to Use (Lifecell Corporation, Branchburg, NJ). Acknowledgements: The authors wish to acknowledge the Department of Scientific Publications at The University of Texas MD Anderson Cancer Center for review and assistance with this manuscript. Corresponding author: Summer E. Hanson, MD, PhD, Department of Plastic Surgery - Unit 1488, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Houston, TX 77030, sehanson@mdanderson.org ©2018American Society of Plastic Surgeons