A comparison of clinical outcomes of acellular dermal matrix with and without radiation sterilization process in immediate prepectoral direct-to-implant breast reconstruction

Abstract

Although there are many acellular dermal matrix (ADM) products, the sterilization process varies for each product. We compared the clinical outcomes of immediate prepectoral direct-to-implant (DTI) breast reconstruction with and without sterilization products. This was a retrospective study of immediate prepectoral DTI breast reconstructions performed between 2018 and 2020. We classified patients depending on whether the used ADM products had undergone radiation sterilization and compared the patient demographics and surgical outcomes, including seroma, infection, mastectomy flap necrosis, capsular contracture, and implant failure. The study included 357 patients, 182 in the no-sterilization group and 179 in the sterilization group. The ADM size differed significantly between the no-sterilization and sterilization groups (122.7cm2 vs. 145.4cm2, respectively, P=0.01). There were no significant differences in overall rates of complications between the two groups, including seroma (P=0.28), infection (P=0.63), mastectomy flap necrosis (P=0.76), and capsular contracture (P=0.76). However, implant failure from infection (0% vs. 3.4%, P=0.01) and drainage amount (690.3mL vs. 779.36mL, P=0.04) with similar removal days were significantly higher in the sterilization group. The authors demonstrated similar complication rates for seroma, infection, mastectomy flap necrosis, and capsular contracture. Whereas a bigger size of ADM was needed to cover a similar implant volume, and drain amount was higher in the sterilization group, the salvage rate from infection was higher in the no-sterilization group with a significant difference.