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Acellular Dermal Matrix Sterility: Does It Affect Microbial and Clinical Outcomes Following Implantation?
Gabriel M Klein1, Gurtej Singh1, Jocellie Marquez1
1Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, N.Y.
Abstract:
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.
Insights
This study found no bacterial growth or increased infection risk in acellular dermal matrices (ADMs) after breast reconstruction surgery, regardless of sterilization method. Findings question the necessity of terminal sterilization for ADMs in breast reconstruction.
Area of Science:
- Plastic Surgery
- Biomaterials Science
- Microbiology
Background:
- Acellular dermal matrices (ADMs) are used in breast reconstruction, but their sterilization methods and impact on infectious complications remain debated.
- Previous research indicated no immediate difference between aseptic and sterilized ADMs, but post-implantation microbial profiles were unexamined.
Purpose of the Study:
- To investigate the microbiologic profiles of acellular dermal matrices (ADMs) after implantation in breast reconstruction.
- To determine if ADM sterilization methods correlate with infectious complications post-implantation.
Main Methods:
- A prospective study involving the collection and culturing of 51 acellular dermal matrix (ADM) samples from 32 patients undergoing tissue expander-based breast reconstruction.
- Samples were excised during stage II expander-implant exchange and incubated to assess microbial growth. Patient records were analyzed for correlations between sterilization, microbial growth, and infectious complications.
Main Results:
- No bacterial growth was observed in any of the 51 cultured acellular dermal matrix (ADM) samples, irrespective of sterilization level (aseptic, 10-3, or 10-6).
- Only one patient experienced a postoperative infectious complication out of 32 patients.
- No statistically significant correlation was found between ADM sterilization method, microbial presence, and postoperative infectious complications.
Conclusions:
- The study found no difference in microbial presence or clinical outcomes between differently sterilized acellular dermal matrices (ADMs) after implantation.
- The absence of bacterial growth in post-implantation samples challenges the routine necessity for terminal sterilization of ADMs in breast reconstruction.
- Further research may clarify the role and optimal processing of ADMs in reconstructive surgery.
