Device to Reduce Surgery Site Contamination
Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow
1 other identifier
interventional
29
1 country
1
Brief Summary
The objective of this study is to determine whether the Air Barrier System device reduces airborne particulate and airborne colony forming units present at a surgery site.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable surgery
Started May 2009
Shorter than P25 for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 4, 2009
CompletedResults Posted
Study results publicly available
May 18, 2010
CompletedMarch 16, 2012
March 1, 2012
4 months
September 2, 2009
April 22, 2010
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgery Site CFU Density
Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol "slit" sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter.
Ten minute intervals throughout surgery
Secondary Outcomes (1)
Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter
Ten minute intervals throughout surgery
Study Arms (3)
No device used
NO INTERVENTIONDevice attached, not activated
SHAM COMPARATORDevice deployed and activated
EXPERIMENTALInterventions
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.
Device is deployed to the surgery site, but the airflow is not activated. This intervention is used to determine any effects that the presence of the device alone may have.
Eligibility Criteria
You may qualify if:
- Candidate for primary total hip arthroplasty
You may not qualify if:
- Prior history of infection
- Revision arthroplasty
- Screens positive for MRSA
- Undergoing hemiarthroplasty or resurfacing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Orthopedic Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.
PMID: 19913327BACKGROUND
Results Point of Contact
- Title
- Sean Self
- Organization
- Nimbic Systems
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Stocks, MD
Fondren Orthopaedic Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 4, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
March 16, 2012
Results First Posted
May 18, 2010
Record last verified: 2012-03