Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

Nimbic Systems

Status: Completed

Conditions: Surgery

Treatments: Device: Air Barrier System device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01559506

ABS-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion criteria

• Active infection
• Prior prosthesis infection

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

No device

No Intervention group

Description:

Subject does not receive ABS system

Air Barrier System device

Experimental group

Description:

Device is deployed adjacent to the surgery site and activated.

Treatment:

Device: Air Barrier System device