Air Barrier System for the Prevention of Prosthesis-related Infections

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.

This research will evaluate ABS performance in a prospective, randomized, blinded
multi-center trial. The surgical procedures studied will include total hip arthroplasty,
trauma-related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic
vascular graft procedures. Patients will be enrolled during the first two years of the study,
and CDC guidelines require a one year follow-up period to monitor patients for potential
prosthesis-related infections.

Inclusion Criteria:

- Total hip arthroplasty;

- Acetabular repair with instrumentation;

- Posterior lumbar, cervical, or thoracic (up to and including 6 vertebral levels) spine
fusion with instrumentation and vascular prosthetic graft implantation.

Exclusion Criteria:

- History of prior prosthesis infection;

- Active infection;

- Open traumatic wounds as is the case after some acetabular fractures.