Air Barrier System for the Prevention of Prosthesis-related Infections

Nimbic Systems

Status: Unknown

Conditions: Prosthesis-Related Infections

Treatments: Device: ABS deployed and NOT active; Device: ABS deployed and active

Study type: Interventional

Funder types: Industry

Identifiers

NCT02376153

ABS004-H-35894

Details and patient eligibility

About

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.

Full 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.

Enrollment: 816 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

816 participants in 2 patient groups

ABS deployed and active

Experimental group

Description:

Air Barrier System (ABS) will be deployed onto the surgical field and activated.

Treatment:

Device: ABS deployed and active

ABS deployed and NOT active

Sham Comparator group

Description:

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.

Treatment:

Device: ABS deployed and NOT active