Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

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

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion criteria

Active infection
Prior prosthesis infection

Treatment and study plan

Air Barrier System Device

Device

Device is deployed adjacent to the surgery site and activated.

Primary outcomes

CFU Density

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Nimbic Systems, LLC

Industry

Registry information

Official study title

ABS to Reduce Contamination in Spine Surgery

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Mar 21, 2012
Registry last updated: Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed