Device to Reduce Surgery Site Contamination - Spine

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: Air Barrier System Device

• Registration Number: NCT01262105
• Lead Sponsor: Nimbic Systems, LLC

Brief 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.

Detailed Description

The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-17
• Results First Submitted: 2012-03-14
• Results First Submitted QC: 2012-03-14
• Status Verified: 2012-04
• Results First Posted: 2012-04-09
• Last Update Submitted: 2012-04-09
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Candidate for instrumented posterior lumbar interbody fusion

Exclusion Criteria

• Prior history of infection
• Revision surgery
• Screens positive for MRSA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device deployed	Air Barrier System Device	-

Primary Outcome Measures

Name	Time	Method
Surgery Site CFU Density	Ten-minute intervals throughout procedure	CFU culture counts for samples taken in surgery.

Trial Locations

Locations (1)

Texas Orthopedic Hospital; 🇺🇸 Houston, Texas, United States