- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559506
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
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
-
-
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 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
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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