Efficacy and Safety of Ethylene Oxide Sterilization of Allogeneic Bone for Human Transplantation: A Forty-year Experience

Prolo, Donald J.; Oklund, Sally; Borer, Mark

doi:10.7759/cureus.121

Cited by 2 publications

(2 citation statements)

References 77 publications

(81 reference statements)

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“…Terminal sterilization is essential for bone allografts to minimize disease transmission and infection. Methods of sterilization such as heat [31,41,42,45,63], hydrogen peroxide [15,24] and ethylene oxide [47,57,65] can negatively affect allograft mechanical and biological properties. Heat treatment greater than 60°C reduces the strength [41,42,45,71,72] and impairs osteoinductivity [44].…”

Section: Introductionmentioning

confidence: 99%

Gamma Radiation Sterilization Reduces the High-cycle Fatigue Life of Allograft Bone

Islam

Chapin

Moore

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background Sterilization by gamma radiation impairs the mechanical properties of bone allografts. Previous work related to radiation-induced embrittlement of bone tissue has been limited mostly to monotonic testing which does not necessarily predict the high-cycle fatigue life of allografts in vivo. Questions/PurposesWe designed a custom rotatingbending fatigue device to answer the following questions:(1) Does gamma radiation sterilization affect the high-cycle fatigue behavior of cortical bone; and (2) how does the fatigue life change with cyclic stress level? Methods The high-cycle fatigue behavior of human cortical bone specimens was examined at stress levels related to physiologic levels using a custom-designed rotatingbending fatigue device. Test specimens were distributed among two treatment groups (n = 6/group); control and irradiated. Samples were tested until failure at stress levels of 25, 35, and 45 MPa. Results At 25 MPa, 83% of control samples survived 30 million cycles (run-out) whereas 83% of irradiated samples survived only 0.5 million cycles. At 35 MPa, irradiated samples showed an approximately 19-fold reduction in fatigue life compared with control samples (12

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Section: Introductionmentioning

confidence: 99%

Gamma Radiation Sterilization Reduces the High-cycle Fatigue Life of Allograft Bone

Islam

Chapin

Moore

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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“…In addition, there is an established evidence base for the use of PAA (e.g., decellularised human dermis), gamma radiation (e.g., allogeneic amniotic membrane, decellularised human dermis, decellularised porcine superflexor tendon), and E Beam (e.g., decellularised porcine superflexor tendon, human flexor digitorum superficialis tendon) indicating possible compatibility with soft tissue grafts ( Singh et al, 2004 , 2016 ; Wei et al, 2013 ; Marsit et al, 2014 ; Hogg et al, 2015 ; Edwards et al, 2017 ; Gabriel and Maxwell, 2018 ). Ethylene oxide was considered for inclusion as a candidate sterilisation method due to its efficacy (in terms of bioburden reduction) and previous history of use in tissue banking, particularly with bone allografts ( Prolo et al, 2013 ). However, the use of ethylene oxide has been associated with the induction of a range of detrimental effects to scaffolds, including compromised biomechanical properties and the deposition of toxic residues ( Mendes et al, 2007 ).…”

Section: Discussionmentioning

confidence: 99%

Effects of Chemical and Radiation Sterilisation on the Biological and Biomechanical Properties of Decellularised Porcine Peripheral Nerves

Holland

Webster

Rooney

et al. 2021

Front. Bioeng. Biotechnol.

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There is a clinical need for novel graft materials for the repair of peripheral nerve defects. A decellularisation process has been developed for porcine peripheral nerves, yielding a material with potentially significant advantages over other devices currently being used clinically (such as autografts and nerve guidance conduits). Grafts derived from xenogeneic tissues should undergo sterilisation prior to clinical use. It has been reported that sterilisation methods may adversely affect the properties of decellularised tissues, and therefore potentially negatively impact on the ability to promote tissue regeneration. In this study, decellularised nerves were produced and sterilised by treatment with 0.1% (v/v) PAA, gamma radiation (25–28 kGy) or E Beam (33–37 kGy). The effect of sterilisation on the decellularised nerves was determined by cytotoxicity testing, histological staining, hydroxyproline assays, uniaxial tensile testing, antibody labelling for collagen type IV, laminin and fibronectin in the basal lamina, and differential scanning calorimetry. This study concluded that decellularised nerves retained biocompatibility following sterilisation. However, sterilisation affected the mechanical properties (PAA, gamma radiation), endoneurial structure and basement membrane composition (PAA) of decellularised nerves. No such alterations were observed following E Beam treatment, suggesting that this method may be preferable for the sterilisation of decellularised porcine peripheral nerves.

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Efficacy and Safety of Ethylene Oxide Sterilization of Allogeneic Bone for Human Transplantation: A Forty-year Experience

Cited by 2 publications

References 77 publications

Gamma Radiation Sterilization Reduces the High-cycle Fatigue Life of Allograft Bone

Gamma Radiation Sterilization Reduces the High-cycle Fatigue Life of Allograft Bone

Effects of Chemical and Radiation Sterilisation on the Biological and Biomechanical Properties of Decellularised Porcine Peripheral Nerves

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