N/A N=36 Randomized Basic Science

Device to Reduce Surgery Site Contamination

Surgery

Bottom Line

View on ClinicalTrials.gov: NCT00972153 ↗

Enrolled (actual)

Serious AEs

—

Results posted

May 2010

Primary outcome: Primary: Surgery Site CFU Density — 7; 11; 0 CFU/cubic meter — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Air Barrier System Device (Device); Sham Air Barrier System device (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Nimbic Systems, LLC
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Surgery Site CFU Density	7; 11; 0	<0.001 sig
SECONDARY Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter	1377; 1165; 247	<0.001 sig

Summary

The objective of this study is to determine whether the Air Barrier System device reduces airborne particulate and airborne colony forming units present at a surgery site.

Eligibility Criteria

Inclusion Criteria

Candidate for primary total hip arthroplasty

Exclusion Criteria

Prior history of infection
Revision arthroplasty
Screens positive for MRSA
Undergoing hemiarthroplasty or resurfacing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00972153). 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.