Air Barrier System for the Prevention of Prosthesis-related Infections
Primary Purpose
Prosthesis-Related Infections
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABS deployed and active
ABS deployed and NOT active
Sponsored by
About this trial
This is an interventional prevention trial for Prosthesis-Related Infections
Eligibility Criteria
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.
Sites / Locations
- Michael E. DeBakey VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
ABS deployed and active
ABS deployed and NOT active
Arm Description
Air Barrier System (ABS) will be deployed onto the surgical field and activated.
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.
Outcomes
Primary Outcome Measures
Clinical incidence of surgical site infection
Subjects are followed for one year post-surgery for onset of prosthesis-related infections .
Secondary Outcome Measures
Full Information
NCT ID
NCT02376153
First Posted
February 25, 2015
Last Updated
September 4, 2018
Sponsor
Nimbic Systems, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02376153
Brief Title
Air Barrier System for the Prevention of Prosthesis-related Infections
Official Title
Air Barrier System for the Prevention of Prosthesis-related Infections
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2015 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nimbic Systems, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis-Related Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
816 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABS deployed and active
Arm Type
Experimental
Arm Description
Air Barrier System (ABS) will be deployed onto the surgical field and activated.
Arm Title
ABS deployed and NOT active
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
ABS deployed and active
Intervention Description
ABS is deployed onto surgical field and is turned on.
Intervention Type
Device
Intervention Name(s)
ABS deployed and NOT active
Intervention Description
ABS is deployed onto surgical field and is NOT turned on.
Primary Outcome Measure Information:
Title
Clinical incidence of surgical site infection
Description
Subjects are followed for one year post-surgery for onset of prosthesis-related infections .
Time Frame
One-year post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Self
Phone
281-565-5715
Email
self@nimbicsystems.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kylie Pflieger
Phone
281-565-5701
Email
k.pflieger@nimbicsystems.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Self
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen C Stewart, MSN
Phone
713-794-7127
Email
Colleen.Cerra-Stewart@va.gov
First Name & Middle Initial & Last Name & Degree
Rabih O Darouiche, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan.
Learn more about this trial
Air Barrier System for the Prevention of Prosthesis-related Infections
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