Einfluss resterilisierter Kunststoffnetze aus Polypropylen auf das Wachstum humaner Fibroblasten - Eine experimentelle in vitro Studie -

Broll, R.; Bethge, Tobias; Windhövel, Ute; Schwandner, O.; Markert, UR; Bruch, H.-P.; Duchrow, M.

doi:10.1055/s-2002-32840

Cited by 8 publications

(2 citation statements)

References 7 publications

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“…There have been few studies that have evaluated the effects of EO sterilisation on the proliferation of fibroblasts cultured on surgical meshes. Autoclave sterilisation at 121 °C, which is used to sterilise some LCM in the developing world, appears to impact the proliferation of fibroblasts, as reported by Broll et al [ 19 ]. Savaris et al [ 27 ] examined the biocompatibility of polylactic acid films after EO sterilisation with fibroblasts in vitro and after implantation in vivo, without finding any toxic effect in either study.…”

Section: Discussionmentioning

confidence: 93%

“…Regarding in vitro evaluations of LCM, few studies have considered the biocompatibility of LCM towards cells. Sanders et al compared the adherence of bacteria on autoclaved LCM and commercially available meshes and found no significant difference between the two types, confirming their safety for human implantation [ 19 ]. Our previous study evaluated the in vitro biocompatibility of LCM using HDFs and reported high proliferation and attachment to LCM, which is now additionally confirmed on EO-sterilised LCM [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of hernia surgical meshes sterilised with ethylene oxide for adoption under UK regulations

Grillo,

Hyder,

Mudera

et al. 2023

Surg Endosc

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Background Low-cost meshes (LCM) have been successfully used in low-income countries (LIC) over the past decades, demonstrating comparable surgical outcomes to commercial meshes at a fraction of the cost. However, LIC sterilisation standards (autoclave sterilisation at 121 °C) do not meet UK regulations for medical devices, which require either ethylene oxide (EO) sterilisation or steam sterilisation at 134 °C. Therefore, the aim of this study was to sterilise UK LCM and characterise their mechanical properties and in vitro biocompatibility to verify whether EO sterilisation causes changes in the mechanical properties and biocompatibility of LCM. Methods EO sterilised LCM were used. Uniaxial tensile tests were performed to measure mechanical properties. Biocompatibility was measured through viability and morphology of Human Dermal Fibroblasts (HDFs) cultured in mesh-conditioned media, and by calculating the metabolic activity and proliferation of HDFs attached on the meshes, with alamarBlue assay. Results Break stress of LCM1 was significantly higher than LCM2 (p < 0.0001), while Young’s modulus of LCM1 was significantly lower than LCM2 (p < 0.05) and there was no significant difference in break strain. Viability and morphology showed no significant difference between LCM and control. Attachment and proliferation of HDFs on LCM showed a better proliferation on LCM2 than LCM1, with values similar to the control at the final time point. Conclusions We demonstrated that EO sterilisation affects LCM mechanical properties, but they still have values closer to the native tissues than the commercially available ones. We also showed that in vitro biocompatibility of LCM2 is not affected by EO sterilisation, as HDFs attached and proliferated on the mesh, while EO affected attachment on LCM1. A more detailed cost analysis of the potential savings for healthcare systems around the world needs to be performed to strengthen the cost-effectiveness of this frugal innovation.

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Evaluation of hernia surgical meshes sterilised with ethylene oxide for adoption under UK regulations

Grillo,

Hyder,

Mudera

et al. 2023

Surg Endosc

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Precoating of alloplastic materials with living human fibroblasts—a feasibility study

Kapischke

Prinz²,

Tepel

et al. 2005

Surg Endosc

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Alterations in the mechanical, chemical and biocompatibility properties of low-cost polyethylene and polyester meshes after steam sterilization

Wiessner¹,

Lorenz²,

Gehring³

et al. 2020

Hernia

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Introduction In Africa and other Low Resource Settings (LRS), the guideline-based and thus in most cases mesh-based treatment of inguinal hernias is only feasible to a very limited extent. This has led to an increased use of low cost meshes (LCMs, mostly mosquito meshes) for patients in LRS. Most of the LCMs used are made of polyethylene or polyester, which must be sterilized before use. The aim of our investigations was to determine changes in the biocompatibility of fibroblasts as well as mechanical and chemical properties of LCMs after steam sterilization. Material and methods Two large-pored LCMs made of polyester and polyethylene in a size of 11 x 6 cm were cut and steam sterilized at 100, 121 and 134 °C. These probes and non-sterile meshes were then subjected to mechanical tensile tests in vertical and horizontal tension, chemical analyses and biocompatibility tests with human fibroblasts. All meshes were examined by stereomicroscopy, scanning electron microscopy (SEM), LDH (cytotoxicity) measurement, viability testing, pH, lactate and glycolysis determination. Results Even macroscopically, polyethylene LCMs showed massive shrinkage after steam sterilization, especially at 121 and 134 °C. While polyester meshes showed no significant changes after sterilization with regard to deformation and damage as well as tensile force and stiffness, only the unsterile polyethylene mesh and the mesh sterilized at 100 °C could be tested mechanically due to the shrinkage of the other specimen. For these meshes the tensile forces were about four times higher than for polyester LCMs. Chemical analysis showed that the typical melting point of polyester LCMs was between 254 and 269 °C. Contrary to the specifications, the polyethylene LCM did not consist of low-density polyethylene, but rather high-density polyethylene and therefore had a melting point of 137 °C, so that the marked shrinkage described above occurred. Stereomicroscopy confirmed the shrinkage of polyethylene LCMs already after sterilization at 100 °C in contrast to polyester LCMs. Surprisingly, cytotoxicity (LDH measurement) was lowest for both non-sterile LCMs, while polyethylene LCMs sterilized at 100 and 121 °C in particular showed a significant increase in cytotoxicity 48 hours after incubation with fibroblasts. Glucose metabolism showed no significant changes between sterile and non-sterile polyethylene and polyester LCMs. Conclusion The process of steam sterilization significantly alters mechanical and structural properties of synthetic hernia mesh implants. Our findings do not support a use of low-cost meshes because of their unpredictable properties after steam sterilization.

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Einfluss resterilisierter Kunststoffnetze aus Polypropylen auf das Wachstum humaner Fibroblasten - Eine experimentelle in vitro Studie -

Cited by 8 publications

References 7 publications

Evaluation of hernia surgical meshes sterilised with ethylene oxide for adoption under UK regulations

Evaluation of hernia surgical meshes sterilised with ethylene oxide for adoption under UK regulations

Precoating of alloplastic materials with living human fibroblasts—a feasibility study

Alterations in the mechanical, chemical and biocompatibility properties of low-cost polyethylene and polyester meshes after steam sterilization

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