Air Barrier System for the Prevention of Prosthesis-related Infections
1 other identifier
interventional
816
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedStudy Start
First participant enrolled
April 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedSeptember 6, 2018
September 1, 2018
4.3 years
February 25, 2015
September 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical incidence of surgical site infection
Subjects are followed for one year post-surgery for onset of prosthesis-related infections .
One-year post surgery
Study Arms (2)
ABS deployed and active
EXPERIMENTALAir Barrier System (ABS) will be deployed onto the surgical field and activated.
ABS deployed and NOT active
SHAM COMPARATORAir 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 is deployed onto surgical field and is turned on.
ABS is deployed onto surgical field and is NOT turned on.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of prior prosthesis infection;
- Active infection;
- Open traumatic wounds as is the case after some acetabular fractures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Self
Investigator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
April 24, 2015
Primary Completion
August 1, 2019
Study Completion
October 1, 2019
Last Updated
September 6, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share
There is no current plan.