Air Barrier System for the Prevention of Prosthesis-related Infections

Prosthesis-Related Infections Clinical Trial

Official title:

Air Barrier System for the Prevention of Prosthesis-related Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02376153
• Other study ID #: ABS004-H-35894
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2015
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Nimbic Systems, LLC
• Contact: Sean Self
• Phone: 281-565-5715
• Email: self[@]nimbicsystems.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 816
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prosthesis-Related Infections

Intervention

Device:
• ABS deployed and active
ABS is deployed onto surgical field and is turned on.
• ABS deployed and NOT active
ABS is deployed onto surgical field and is NOT turned on.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nimbic Systems, LLC

Country where clinical trial is conducted

United States, 

Outcome

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