N/A
N=41
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01559506 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: CFU Density — 5.05; 1.55 CFU/m^3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Air Barrier System device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nimbic Systems, LLC
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CFU Density |
5.05; 1.55 | — |
Summary
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures
Eligibility Criteria
Inclusion Criteria
- Adult patients undergoing lumbar and cervical laminectomy with instrumentation.
Exclusion Criteria
- Active infection
- Prior prosthesis infection
Data sourced from ClinicalTrials.gov (NCT01559506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.