Air Barrier System for the Prevention of Prosthesis-related Infections

DESCRIPTION (provided by applicant): This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis- related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision. Preliminary findings in the ongoing NIH/SBIR Phase II study, after enrolling 258 patients in a single-site trial at the DeBakey Veterans Affairs Medical Center (VAMC) in Houston, indicate a positive trend for the ABS to reduce the clinical incidence of prosthesis-related infection in hip replacement, posterior spinal fusion, and prosthetic vascular graft procedures. Furthermore, preliminary data trends indicate that higher levels of airborne microorganisms in surgical theatres are correlated to an increased incidence of prosthesis-related infections and that the ABS significantly reduces the presence of these orga