Air Barrier System for the Prevention of Prosthesis-related Infections

DESCRIPTIONprovided by applicantThis project is an evaluation of a novel devicethe Air Barrier SystemABSto reduce the risk of prosthesisrelated surgical site infection in a multi center clinical trialThe ABS shields surgical incisions intra operatively by creating a field of high purity air surrounding an incision that prevents airborne microorganisms from entering the incisionPreliminary findings in the ongoing NIH SBIR Phase II studyafter enrollingpatients in a single site trial at the DeBakey Veterans Affairs Medical CenterVAMCin Houstonindicate a positive trend for the ABS to reduce the clinical incidence of prosthesis related infection in hip replacementposterior spinal fusionand prosthetic vascular graft proceduresFurthermorepreliminary 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 organisms during surgical proceduresNimbic Systems has formed a consortium with researchers and surgeons at Baylor College of MedicineVAMC and Ben Taub General hospitalsin Houston and University of Texas Medical Branch at GalvestonTexas Department of Criminal Justice HospitalThese institutions were selected specifically because the reported infection rates in the targeted surgical procedures are highthey perform a broad range of surgical services and can provide adequate enrollment volumeand patient follow up compliance is highResearch performed will include participation by both Nimbic employees and consortium contributorsThis Phase IIB research will evaluate ABS performance in a prospectiverandomizedblinded multi center trial expanded tosurgical casesThe surgical procedures studied will include total hip arthroplastytraumarelated acetabula reconstructionposterior instrumented spine fusionand prosthetic vascular graft proceduresPatients will be enrolled during the first two years of the studyand CDC guidelines require a one year followup period to monitor patients for potential prosthesis related infectionsThe projectandapos s key aims are tocompare the incidence of implant related infections between the control and ABS groupsdetermine whether increased levels of airborne microorganisms in surgical theatres are correlated to an increase in the incidence of surgical site infectionsdetermine if a risk assessment model can be constructed to predict the incidence of infection based on airborne CFU levelsevaluate user satisfaction with the ABS device and develop device improvements PUBLIC HEALTH RELEVANCEPatients contracting a surgical site infectionSSIafter high risk surgical procedures face considerable hardshipsand evidence shows that elderlyless affluentand non urban populations are more likely to succumb to an SSIThe cost of treating surgical site infections developing after high risk surgeries is up to $billion annually and is projected to grow rapidly through the yearThe goal of this project is to conduct a multi center clinical trial to evaluate the ability of a novel devicethe Air Barrier Systemandquotto reducethe risk of SSI in prosthesis implant surgery procedures