Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

Not Applicable

Completed

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

• Registration Number: NCT01559506
• Lead Sponsor: Nimbic Systems, LLC

Brief 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

Detailed Description

The ABS 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 ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-21
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2015-02-25
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-16
• Last Update Submitted: 2015-03-16
• Results First Posted: 2015-03-17
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion Criteria

• Active infection
• Prior prosthesis infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air Barrier System device	Air Barrier System device	Device is deployed adjacent to the surgery site and activated.

Primary Outcome Measures

Name	Time	Method
CFU Density	Surgical case CFU density will be determined at up to 1 month from completion of surgical cases	Colony-forming unit density at incision site (CFU/m3)

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States