Air Barrier System for the Prevention of Prosthesis-related Infections

Not Applicable

• Conditions: Prosthesis-Related Infections
• Interventions: Device: ABS deployed and NOT active; Device: ABS deployed and active

• Registration Number: NCT02376153
• Lead Sponsor: Nimbic Systems, LLC

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 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.

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Study Start: 2015-04-24
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06
• Primary Completion: 2019-08
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 816

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABS deployed and NOT active	ABS deployed and NOT active	Air Barrier System (ABS) will be deployed onto the surgical field and NOT activated. This is a sham comparator to reduce the influence of the presence of the device and provide user blinding.
ABS deployed and active	ABS deployed and active	Air Barrier System (ABS) will be deployed onto the surgical field and activated.

Primary Outcome Measures

Name	Time	Method
Clinical incidence of surgical site infection	One-year post surgery	Subjects are followed for one year post-surgery for onset of prosthesis-related infections .

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States