Clinical Trial: Air Barrier System for the Prevention of Prosthesis-related Infections

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Air Barrier System for the Prevention of Prosthesis-related Infections

Brief Summary: This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.

Detailed Summary:

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.


Sponsor: Nimbic Systems, LLC

Current Primary Outcome: Clinical incidence of surgical site infection [ Time Frame: One-year post surgery ]

Subjects are followed for one year post-surgery for onset of prosthesis-related infections .


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Nimbic Systems, LLC

Dates:
Date Received: February 25, 2015
Date Started: April 2015
Date Completion: June 2018
Last Updated: March 27, 2017
Last Verified: March 2017