NCT02376153

Air Barrier System for the Prevention of Prosthesis-related Infections

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 816 (estimated)
• Sponsor: Nimbic Systems, LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Prosthesis-Related Infections

Interventions

Type	Name	Description
DEVICE	ABS deployed and active	ABS is deployed onto surgical field and is turned on.
DEVICE	ABS deployed and NOT active	ABS is deployed onto surgical field and is NOT turned on.

Timeline

• Start date: 2015-04-24
• Primary completion: 2019-08-01
• Completion: 2019-10-01
• First posted: 2015-03-03
• Last updated: 2018-09-06

Locations

1 site across 1 country: United States