Air Barrier System for the Prevention of Prosthesis-related Infections

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prosthesis-Related Infections

Intervention / Treatment
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* Device: ABS deployed and active
* Device: ABS deployed and NOT active


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABS deployed and active<br>Air Barrier System (ABS) will be deployed onto the surgical field and activated. | Device: ABS deployed and active<br>* ABS is deployed onto surgical field and is turned on.<br>|
| Sham Comparator: ABS deployed and NOT active<br>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. | Device: ABS deployed and NOT active<br>* ABS is deployed onto surgical field and is NOT turned on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical incidence of surgical site infection | Subjects are followed for one year post-surgery for onset of prosthesis-related infections . | One-year post surgery |