Device to Reduce Surgery Site Contamination - Spine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Orthopedic Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Candidate for instrumented posterior lumbar interbody fusion

Exclusion criteria

Prior history of infection
Revision surgery
Screens positive for MRSA

Treatment and study plan

Air Barrier System Device

Device

Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.

Primary outcomes

Surgery Site CFU Density

Time frame: Ten-minute intervals throughout procedure

CFU culture counts for samples taken in surgery.

Sponsors and collaborators

Lead sponsor

Nimbic Systems, LLC

Industry

Registry information

Official study title

Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 17, 2010
Registry last updated: Apr 11, 2012

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