Device to Reduce Surgery Site Contamination - Spine

Nimbic Systems

Status: Completed

Conditions: Surgery

Treatments: Device: Air Barrier System Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262105

ABS-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate for instrumented posterior lumbar interbody fusion

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

No device

No Intervention group

Device deployed

Experimental group

Treatment:

Device: Air Barrier System Device