Safety and Efficacy of Ethylene Oxide Gas Sterilized Acellular Allogenic Dermis

ABSTRACT

The human acelluar allogenic dermis has been used for soft tissue augmentation of sunken areas. Because of high price, extra-acelluar allogenic dermis is resterilized after being used. The purpose of this experiment is to evaluate the safety and efficacy of ethylene oxide (E.O) gas sterilized acellular allogenic dermal graft(Sure Derm(R)). Twenty-four white rats, weighing about 200 grams and of 5 weeks of age were divided into 3 groups. The prepared SureDerm(R) sheets(10x10mm sized , each 1 mm in thickness) were implanted into the pockets of back area. Biopsy specimens were taken after 4, 8 and 12 weeks and examined histologically for inflammatory reaction, neocollagen synthesis. The initial volume of the graft was measured by immersing it in a 2cc of normal saline and the volume of fluid displaced was checked. The changes in graft volume were measured by the same method. There was a tiny decrease in the volume of the E.O. gas sterilized graft. However, there was no significant difference in the survival rate among the groups(p<0.05). Histological analysis demonstrated progressive monocytes and fibroblast infiltration, sparce collagen bundle organization with time in E.O. gas sterilized grafts. Our experimental study suggests that E.O. gas re- sterilized SureDerm(R) might not be a safe material to use as an implant.