Air Barrier System for the Prevention of Prosthesis-related Infections

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02376153

Enrollment

816

Registered

2015-03-03

Start date

2015-04-24

Completion date

2019-10-31

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 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.

Interventions

DEVICEABS deployed and active

ABS is deployed onto surgical field and is turned on.

DEVICEABS deployed and NOT active

ABS is deployed onto surgical field and is NOT turned on.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactSean Self

self@nimbicsystems.com281-565-5715

Backup ContactKylie Pflieger

k.pflieger@nimbicsystems.com281-565-5701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026