Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

March 16, 2015 updated by: Nimbic Systems, LLC

ABS to Reduce Contamination in 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion Criteria:

  • Active infection
  • Prior prosthesis infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No device
Subject does not receive ABS system
Experimental: Air Barrier System device
Device is deployed adjacent to the surgery site and activated.
Device: Air Barrier System device
Device is deployed adjacent to the surgery site and activated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Surgical case CFU density will be determined at up to 1 month from completion of surgical cases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nimbic Systems, LLC

Investigators

  • Principal Investigator: Rabih O Darouiche, MD, Baylor College of Medicine
  • Principal Investigator: Sean Self, Nimbic Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ABS-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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