N/A N=23 Randomized Double-blind Basic Science

Device to Reduce Surgery Site Contamination - Spine

Surgery

Bottom Line

View on ClinicalTrials.gov: NCT01262105 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2012

Primary outcome: Primary: Surgery Site CFU Density — 3.08; 1.73 CFU/m3

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Air Barrier System Device (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Nimbic Systems, LLC
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Surgery Site CFU Density	3.08; 1.73	—

Summary

The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.

Eligibility Criteria

Inclusion Criteria

Candidate for instrumented posterior lumbar interbody fusion

Exclusion Criteria

Prior history of infection
Revision surgery
Screens positive for MRSA

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Data sourced from ClinicalTrials.gov (NCT01262105). 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.