Acellular Dermal Matrix Sterility: Does it Affect Microbial and Clinical Outcomes Following Implantation for Breast Reconstruction
Gabriel M. Klein, MD, MS, Jocellie Marquez, MD, Gurtej Singh, PhD, Matthew Gebre, BS, Robert Barry, BA, Michael Trostler, MD, Tara L. Huston, MD, Jason C. Ganz, MD, Sami U. Khan, MD, Alexander B. Dagum, MD, Duc T. Bui, MD
Stony Brook University Hospital, Stony Brook, NY, USA.
Introduction: There has been much debate regarding the use of Acellular Dermal Matrices (ADM) in breast reconstruction and the risk for postoperative infectious complications. Recent literature has further investigated the effects of ADM sterilization on these complications, although with varying conclusions. Previous work by our group examining the microbiological profile of sterile and aseptic ADM showed no significant difference between aseptic and sterilized products immediately out of the package. In this study we investigate the microbiologic profiles of these agents after implantation.
Methods: In this prospective study we sampled previously implanted samples of ADM. These ADMs were implanted during the first stage of tissue expander based immediate breast reconstruction, and a 1cm squared sample was excised during the stage II expander-implant exchange procedure. Samples were incubated and cultured for 48 hours in tryptic soy broth. Those samples which showed growth were further cultured on tryptic soy broth and blood agar plates. Patient records were also analyzed, to determine if ADM sterilization and microbial growth were correlated with infectious complications following the stage I and stage II operations.
Results: A total of 51 samples of ADM were collected from 32 patients. Six samples were from aseptic ADM (Alloderm), 27 were collected from ADM sterilized to 10^-3 (Alloderm RTU), and 18 samples were from products sterilized to 10^-6 (Allomax). None of the samples demonstrated bacterial growth. Only 3 of the patients experienced postoperative cellulitis between the initial implantation of ADM and the second stage of reconstruction. Two of these patients also developed deep space infections. There was no statistically significant correlation between the ADM used and the degree of ADM sterility.
Conclusions: Our findings showed no discernible difference in microbial presence and clinical outcomes when comparing the varying degrees of ADM sterility. Furthermore, patients experiencing postoperative infections did not show bacterial growth when the ADM was cultured during the expander-implant swap procedure. Our study did not demonstrate a clinical microbiological difference between aseptic or sterile ADM products when used for tissue expander based breast reconstruction.
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