Uni-axial Tensile Testing of Two Amniotic Membrane Products: Artacent Wound® and Artacent Wound Pro®

Introduction: Amniotic membrane is a promising biomaterial for regenerative medicine, with numerous placental membrane products available on the market for various applications.  A standardized method for Tensile testing using an Instron 5544 has been established (1). This study applies this method to two dual-layer amnion products used in advanced wound care: Artacent WoundTM, sterilized with E-beam, and Artacent Wound ProTM, sterilized using supercritical CO2 plus a sterilant. Additionally, this test method assesses a competitive amniotic product sold in the US.Methods:Tensile testing of the three products was conducted at room temperature in dry conditions to mimic clinical handling. The method involves the following steps:1. Compressible, nonslip lining material cut to size and applied to Instron jaw faces.2. ASTM D1708 dog bone die cutter used to cut samples to standard size and shape.3. Width and thickness measurements of sample taken in triplicate and averaged.4. Force sensor calibrated.5. Tare load of 0.5N applied to sample prior to start.6. Length measurements of product taken.7. Length, width, and thickness measurements entered into Bluehill Software.8. Strain rate of 0.40 mm/min entered into software.9. "Zero displacement" selected.10. Test started until full sample break achieved.11. Test stopped and data collected.Data Analysis:One-way ANOVA Multicomparison Tukey Tests were used to compare the three test groups.Results:Comparative graphs summarize the failure stress (MPa), failure strain (%), and Young's Modulus (MPa) for the three test groups.Discussion: Differences among the measured biomechanical properties of Artacent WoundTM, Artacent Wound ProTM, and the competitive product are highlighted in the figures.The study confirmed that the supercritical CO2 sterilization method used for Artacent Wound ProTM did not compromise the membrane's structural integrity or handling characteristics. Additionally, this method provided an environmentally friendly alternative to traditional e-beam sterilization.These findings suggest that the advanced sterilization technique employed for Artacent Wound ProTM can maintain or enhance the functional properties of amniotic membrane products. The competitive product also showed comparable biomechanical properties, indicating that all three products are viable options for clinical use.In conclusion, the tensile testing confirmed that both Artacent WoundTM and Artacent Wound ProTM possess the necessary mechanical properties for effective wound management. The use of supercritical CO2 sterilization presents a promising advancement in the sterilization of amniotic membrane products.References: