Optimization of Novel Human Acellular Dermal Dressing Sterilization for Routine Use in Clinical Practice.

Gamma rays and electrons with kinetic energy up to 10 MeV are routinely used to sterilize biomaterials. To date, the effects of irradiation upon human acellular dermal matrices (hADMs) remain to be fully elucidated. The optimal irradiation dosage remains a critical parameter affecting the final product structure and, by extension, its therapeutic potential. ADM slides were prepared by various digestion methods. The influence of various doses of radiation sterilization using a high-energy electron beam on the structure of collagen, the formation of free radicals and immune responses to non-irradiated (native) and irradiated hADM was investigated. The study of the structure changes was carried out using the following methods: immunohistology, immunoblotting, and electron paramagnetic resonance (EPR) spectroscopy. It was shown that radiation sterilization did not change the architecture and three-dimensional structure of hADM; however, it significantly influenced the degradation of collagen fibers and induced the production of free radicals in a dose-dependent manner. More importantly, the observed effects did not disrupt the therapeutic potential of the new transplants. Therefore, radiation sterilization at a dose of 35kGy can ensure high sterility of the dressing while maintaining its therapeutic potential.

Poly(epsilon-caprolactone) biomaterial sterilized by E-beam irradiation.

The effects of ionizing radiation (electron beam) on poly(epsilon-caprolactone) (PCL) were studied by analyzing changes in viscosity-average and weight-average molecular weight and radius of gyration, and by performing sol-gel analysis and swelling tests. Samples were irradiated under various conditions: solid and molten PCL in the presence or absence of air. The overall efficiency of crosslinking is higher for samples irradiated in the molten state than in the solid state, and is reduced in the presence of oxygen. Based on three kinds of experiments (molecular weight dependence on the dose in the pre-gelation region, sol-gel analysis, and swelling study), radiation-chemical yields of intermolecular crosslinking and scission were determined and are discussed in terms of the mechanism of radiation-induced reactions in PCL. Properties of the gels formed by high-dose irradiation and mechanical properties of irradiated PCL were analyzed. Irradiation causes an increase in the compression modulus of PCL. This process occurs at the pre-gelation stage and continues in the gel-containing system. We have demonstrated, for the first time, that irradiation of solid PCL is accompanied by a pronounced post-effect, which manifests itself by changes in the average molecular weight. EPR data indicate that this effect, at least in part, is caused by the presence of long-lived radicals trapped in the crystalline regions. Irradiation with the sterilizing dose does not cause a statistically significant change in the biocompatibility of PCL after subsequent storage for 79 d, as determined by preliminary osteoblast vitality tests.