Comparison of Tensile Properties of Amniotic Membranes Sterilized with Different Techniques

The amniotic membrane has gained recognition as a promising biomaterial in the field of regenerative medicine. The market offers a diverse range of placental membrane products designed for various applications. When evaluating and characterizing the numerous amniotic products available, it becomes crucial to ensure that each product aligns with the specific user requirements, particularly concerning the mechanical characteristics for wound care applications. One effective method for testing this characteristic involves tensile testing. In this study, the Instron 5544 was used to test tensile strength of two different amniotic products. A standardized and optimized procedure for conducting tensile tests on amniotic products has not been previously well-established. This study addresses this gap by introducing a standardized test method for the tensile testing of dehydrated amniotic membrane. Through this study, we compare the handling capabilities of Artacent Wound®, a dual layer amniotic scaffold, sterilized with electron beam (e-beam) sterilization, to Artacent Wound® sterilized using an alternative sterilization technique.<br/> <br/>Multiple sterilization techniques, such as gamma irradiation, ethylene oxide (ETO) gas sterilization, e-beam, and several other approaches have been utilized to remove potential pathogens for products derived from human placentas. However, the sterilization method can lead to diverse impacts on the material's mechanical characteristics. To ensure that the mechanical properties are maintained with the alternative sterilization technique, the Artacent Wound® product is compared to the e-beam sterilized Artacent Wound® product.<br/><br/>Tensile tests were performed on two different Artacent Wound® products (one with e-beam sterilization and one with an alternative sterilization technique), and the products were tested for Failure Stress (MPa), Failure Strain (%), and Young’s Modulus (MPa). The tests were used to characterize and better understand the product’s mechanical properties and how the sterilization techniques impact these properties. By developing a method to test tensile strength for amniotic products, new products and new processing steps can be easily tested to determine the mechanical impacts to the product.