Recruiting

Air Barrier System

Sponsor:

Nimbic Systems, LLC

Code:

NCT02376153

Conditions

Prosthesis-Related Infections

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

ABS deployed and active

ABS deployed and NOT active

Study Details

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.

Conditions

Prosthesis-Related Infections

Study ID

NCT02376153

Start date

Apr 24, 2015

Status verified date

Sep, 2018

Completion date

Oct, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Enrollment

816 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ABS deployed and active

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

sham comparator: 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.

Interventions

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.

Primary outcome measure

  • Clinical incidence of surgical site infection [ Time Frame: One-year post surgery ]

Central Contacts and Locations

Central contacts

Sean Self

281-565-5715self@nimbicsystems.com

Kylie Pflieger

281-565-5701k.pflieger@nimbicsystems.com

Locations

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Colleen C Stewart, MSN

713-794-7127Colleen.Cerra-Stewart@va.gov

Principal Investigator:

Rabih O Darouiche, MD

More Information

Sponsor

Nimbic Systems, LLC

Last update posted

Sep 6, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nimbic Systems, LLC on 2018-09-06.