Air Barrier System for the Prevention of Prosthesis-related Infections
NCT ID: NCT02376153
Last Updated: 2018-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
816 participants
INTERVENTIONAL
2015-04-24
2019-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ABS deployed and active
Air Barrier System (ABS) will be deployed onto the surgical field and activated.
ABS deployed and active
ABS is deployed onto surgical field and is turned on.
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.
ABS deployed and NOT active
ABS is deployed onto surgical field and is NOT turned on.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Active infection;
* Open traumatic wounds as is the case after some acetabular fractures.
21 Years
ALL
No
Sponsors
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Nimbic Systems, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Sean Self
Role: PRINCIPAL_INVESTIGATOR
Investigator
Locations
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Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ABS004-H-35894
Identifier Type: -
Identifier Source: org_study_id
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