Acellular Dermal Matrix Sterility: Does It Affect Microbial and Clinical Outcomes Following Implantation?

Abstract

Introduction:The use of acellular dermal matrices (ADMs) in breast reconstruction is a controversial topic. Recent literature has investigated the effects of ADM sterilization on infectious complications, although with varying conclusions. Previous work by our group showed no 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 cultured samples of ADM previously implanted during the first stage of tissue expander-based immediate breast reconstruction. A 1 cm2 sample was excised during the stage II expander–implant exchange procedure, and samples were incubated for 48 hours in tryptic soy broth. Samples with 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.Results:In total, 51 samples of ADM were collected from 32 patients. Six samples were from aseptic ADM (AlloDerm), 27 samples were from ADM sterilized to 10–3 (AlloDerm Ready-to-Use), and 18 samples were from products sterilized to 10–6 (AlloMax). No samples demonstrated bacterial growth. Only 5 patients experienced postoperative complications, of whom only 1 patient was infectious in nature. We failed to demonstrate a statistically significant correlation between sterility and postoperative complications.Conclusions:Our findings showed no difference in microbial presence and clinical outcomes when comparing ADM sterility. Furthermore, no samples demonstrated growth in culture. Our study brings into question the necessity for terminal sterilization in these products.

Early Complications after Prepectoral Tissue Expander Placement in Breast Reconstruction with and without Acellular Dermal Matrix

“…10,11 However, literature examining infectious outcomes in sterile versus aseptic ADM have produced mixed results, with some citing improved outcomes with the use of sterile products and others reporting no difference. [31][32][33] The identification of minor differences in postoperative complications between the ADM and no-ADM groups in our study, along with recent studies affirming these results, suggest that a more judicious application of ADM in tissue expander placement may be warranted. Proponents of ADM cite aesthetic benefits in the final reconstruction as a rationale for its use including reduced incidence of capsular contracture, decreased occurrences of implant displacement, enhanced lower pole curvature, and greater definition of the inframammary and lateral mammary folds.…”

“…10,11 However, literature examining infectious outcomes in sterile versus aseptic ADM have produced mixed results, with some citing improved outcomes with the use of sterile products and others reporting no difference. 31–33…”

Quantity of Acellular Dermal Matrix in Immediate Breast Reconstruction and Outcomes

“…In viewing ADM burden as a dose-response relationship to infection, in this setting of increased quantity of ADM burden, it is no surprise that infection rates were 5 times greater in this patient population. The literature examining the microbiologic properties and clinical outcomes between aseptic and sterilized ADM has had mixed results, with some citing no differences while others suggest improved outcomes with sterile ADM. 16,23,24 Surgical technique for total wrap can vary between providers. At our institution, typically the entirety of the implant, both anterior and posterior, is draped with the uniform piece of ADM.…”

Comparison of irradiated and non-irradiated acellular dermal matrices in breast reconstruction under radiotherapy

“…Buseman et al [ 19 ] reported significantly higher seroma rates in the sterile AlloDerm ready-to-use (RTU; LifeCell Corporation, Branchburg, NJ, USA) group (P=0.003) than in the aseptic AlloDerm freeze-dried (FD; LifeCell Corporation) group, but no differences in infection rates. In a similar context, in a prospective study by Klein et al [ 20 ], ADM samples from the first stage of tissue expander-based immediate breast reconstruction were cultured. No growth was found in any cultures, leading the authors to question the need for terminal sterilization of ADM.…”