Is Sterile Better Than Aseptic? Comparing the Microbiology of Acellular Dermal Matrices

Klein, Gabriel; Nasser, A; Phillips, Brett T.; Gersch, Robert P.; Fourman, Mitchell S.; Lilo, Sarit; Fritz, Jason R.; Khan, Sami U.; Dagum, Alexander B.; Bui, Duc T.

doi:10.1097/gox.0000000000000705

Cited by 11 publications

(7 citation statements)

References 34 publications

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“…Several mechanisms have been proposed for how ADMs may lead to infection, including contamination during production, contamination during placement, and seeding from the body postoperatively. When reviewing the results of our previous study investigating microbial growth of ADMs before implantation, 15 we believed that the clinical effect of pre- or perioperative seeding was unlikely. With all culture results failing to show growth, in vivo study was felt to be the next appropriate step.…”

Section: Discussionmentioning

confidence: 99%

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

Klein

Singh

Marquez

et al. 2019

Plastic and Reconstructive Surgery - Global Open

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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.

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Section: Discussionmentioning

confidence: 99%

“…13,14 In an earlier study performed by our group, we investigated the in vitro effects of sterilization when compared with aseptic processing. 15 A total of 92 samples of ADM were sterilely harvested out of the package before implantation. The samples were taken from both sterile and aseptically processed ADM.…”

Section: Introductionmentioning

confidence: 99%

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

Klein

Singh

Marquez

et al. 2019

Plastic and Reconstructive Surgery - Global Open

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“…Other published series on AlloDerm RTU, however, have reported higher infection rates, ranging from 6.0% to 25.0%. 15 – 17 , 19 , 20 Although it is difficult to comment on the disparity in infection rates between studies, we believe that strict adherence to aseptic techniques is critical to minimize the risk, even when using a sterile graft.…”

Section: Discussionmentioning

confidence: 99%

AlloDerm RTU Integration and Clinical Outcomes When Used for Reconstructive Breast Surgery

Gabriel

Maxwell

2018

Plastic and Reconstructive Surgery - Global Open

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Background:AlloDerm Ready To Use (RTU) is a sterile version of AlloDerm regenerative tissue matrix, developed in response to concerns regarding the potential risk of infectious complications with the latter aseptic matrix. Clinical data on AlloDerm RTU use is, however, limited, particularly with respect to histologic evidence of graft integration and clinical outcomes.Methods:Consecutive patients who underwent tissue-expander/implant reconstruction with the use of AlloDerm RTU from March 2011 to September 2012 were included in this analysis. Biopsies of AlloDerm RTU/capsule interface were obtained at the time of expander/implant exchange and evaluated for evidence of cellularization, vascularization, and inflammatory reaction. Data on postoperative complications were retrieved from patient records.Results:A total of 116 biopsy specimens from 68 patients were obtained. At biopsy, on visual inspection, nearly all grafts were fully integrated within the host tissue. Histologically, graft specimens demonstrated mild-to-moderate neovascularization and cellular repopulation with no inflammatory cells. All patients were followed for 5 years postoperatively. Short-term postoperative complications of skin necrosis, seroma, and infection occurred in 10.3%, 4.3%, and 2.6% of reconstructions, respectively. Capsular contracture (grade 3) was the only long-term complication (5.2%). Rates of short- and long-term complications are similar to those observed in our previous experience with AlloDerm reconstructive tissue matrix.Conclusions:AlloDerm RTU used in breast reconstructive surgery fully integrates and incorporates into host tissue. There were no unexpected safety concerns with its use at short-term or at long-term, at least up to 5 years of follow-up.

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“…176 Some studies have suggested that aseptic processing is more beneficial than sterilisation, but others have found them to be equivalent, and there is currently no consensus on optimal processing. 177,178…”

Section: Discussionmentioning

confidence: 99%

Clinical applications of acellular dermal matrices: A review

Petrie

Cox

Becker

2022

Scars, Burns & Healing

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Introduction The extracellular matrix (ECM) plays an integral role in wound healing. It provides both structure and growth factors that allow for the organised cell proliferation. Large or complex tissue defects may compromise host ECM, creating an environment that is unfavourable for the recovery of anatomical function and appearance. Acellular dermal matrices (ADMs) have been developed from a variety of sources, including human (HADM), porcine (PADM) and bovine (BADM), with multiple different processing protocols. The objective of this report is to provide an overview of current literature assessing the clinical utility of ADMs across a broad spectrum of applications. Methods PubMed, MEDLINE, EMBASE, Scopus, Cochrane and Web of Science were searched using keywords ‘acellular dermal matrix’, ‘acellular dermal matrices’ and brand names for commercially available ADMs. Our search was limited to English language articles published from 1999 to 2020 and focused on clinical data. Results A total of 2443 records underwent screening. After removing non-clinical studies and correspondence, 222 were assessed for eligibility. Of these, 170 were included in our synthesis of the literature. While the earliest ADMs were used in severe burn injuries, usage has expanded to a number of surgical subspecialties and procedures, including orthopaedic surgery (e.g. tendon and ligament reconstructions), otolaryngology, oral surgery (e.g. treating gingival recession), abdominal wall surgery (e.g. hernia repair), plastic surgery (e.g. breast reconstruction and penile augmentation), and chronic wounds (e.g. diabetic ulcers). Conclusion Our understanding of ADM’s clinical utility continues to evolve. More research is needed to determine which ADM has the best outcomes for each clinical scenario. Lay Summary Large or complex wounds present unique reconstructive and healing challenges. In normal healing, the extracellular matrix (ECM) provides both structural and growth factors that allow tissue to regenerate in an organised fashion to close the wound. In difficult or large soft-tissue defects, however, the ECM is often compromised. Acellular dermal matrix (ADM) products have been developed to mimic the benefits of host ECM, allowing for improved outcomes in a variety of clinical scenarios. This review summarises the current clinical evidence regarding commercially available ADMs in a wide variety of clinical contexts.

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Is Sterile Better Than Aseptic? Comparing the Microbiology of Acellular Dermal Matrices

Cited by 11 publications

References 34 publications

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

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

AlloDerm RTU Integration and Clinical Outcomes When Used for Reconstructive Breast Surgery

Clinical applications of acellular dermal matrices: A review

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