Assessment of the Healing Rate of Artacent Wound Pro, a Dual Layer Amnion Wound Covering Sterilized with a Novel Process

Introduction: Placenta-based scaffolds are known for their regenerative potential in various clinical applications, often requiring terminal sterilization to ensure safety. The choice of sterilization method can impact the biological activity and clinical performance of these products. This study evaluates the effects of two sterilization methods of placenta-based products on wound healing rate using a challenge size (2x2 cm) full-thickness wound model in Sprague Dawley rats.Methods:Artacent WoundTM (E-Beam sterilized) and Artacent Wound ProTM (supercritical CO2 sterilized) amniotic membrane grafts were processed using identical manufacturing techniques. Full-thickness wounds (2x2 cm) were created on the dorsal side of rats, with implants randomized into sites and harvested after 4 and 7 days. Healing was assessed via gross analysis as well as histological analysis for re-epithelialization, cellular infiltration, and remodeling.Results:Wound closure, re-epithelialization, and granulation tissue formation were measured, showing that both sterilization methods supported wound healing. The supercritical CO2 method demonstrated improved healing compared to E-beam sterilization, with no adverse effects observed.Discussion: Both products sterilized the two different ways promoted wound healing in the rat model. The supercritical CO2 process maintained tissue integrity and provided an environmentally friendly approach, with improved healing outcomes compared to E-beam sterilization. Artacent Wound ProTM showed enhanced wound healing, increased wound closure, equivalent re-epithelialization, and increased granulation tissue formation compared to the original Artacent WoundTM. Both sterilization methods were effective at achieving sterility assurance level of 10-6 log reduction in bacterial load while maintaining tissue architecture, histological properties, and biochemical properties of the placental membranes. References: