“One goal of this clinical trial is to determine the effectiveness of this new technology at reducing bacterial contamination of surgical incisions,” said Rabih O. Darouiche, M.D., VA Distinguished Service Professor in the departments of Physical Medicine and Rehabilitation, Medicine, and Surgery and the study’s principal investigator.
As a result of a $1.2 million award from the National Institutes of Health, the Michael E. DeBakey VA Medical Center (MEDVAMC) is initiating a pilot study of a novel device to determine its ability to reduce bacterial contamination and decrease the incidence of surgical site infection after surgical procedures requiring insertion of prostheses.
“This randomized, controlled clinical trial will investigate the incidence of surgical site infection occurring after hip arthroplasty, vertebral fusion, and femoral-popliteal grafting procedures performed over a twoyear period,” said Rabih O. Darouiche, M.D., VA Distinguished Service Professor in the departments of Physical Medicine and Rehabilitation, Medicine, and Surgery and the study’s principal investigator.
Surgical site infections are a serious postoperative complication affecting almost 500,000 patients annually. In particular, infections occurring after surgical implementations of prostheses cause severe illness and the cost of treatment can reach $100,000 per incidence.
Most infections occurring after surgical implantation of prostheses are caused by microorganisms that become attached to the implants at the time of surgery. Research published in peer-reviewed journals indicate that a common source of these bacteria are skin cells shed by operating room personnel into the airborne environment that settle onto the surgical field.
“The Air Barrier System is intended to shield surgical sites from airborne contaminants in the operating room by creating a localized ‘cocoon’ of ultraclean air surrounding incisions. This prevents the intrusion of airborne contaminants by sweeping them away,” said Darouiche, who is also the founder and director of the Center for Prostheses Infection at Baylor College of Medicine. “The ABS is currently approved by the Food and Drug Administration for use in hip surgery and does not interfere with the procedure.”
During a Phase I Clinical Study published in the Journal of Arthroplasty, the ABS reduced the presence of bacteria at incision sites during hip arthroplasty by 84 percent as compared to the ambient air present in surgical theatres.
The goals of this clinical trial are to determine the effectiveness of the ABS at reducing bacterial contamination of surgical incisions and detect trends in the rates of surgical site infection between the experimental group that uses the ABS versus the control group that does not.
Veterans undergoing orthopedic, neurosurgical or vascular surgical procedures that entail implantation of prostheses will be eligible for study enrollment.
“Should the study yield promising results, the research conducted at Michael E. DeBakey VA Medical Center could lead to a breakthrough in addressing infection prevention in the operating room environment,” said Darouiche.