Device to Reduce Surgery Site Contamination
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|ClinicalTrials.gov Identifier: NCT00972153|
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : May 18, 2010
Last Update Posted : March 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Surgery||Device: Air Barrier System Device Device: Sham Air Barrier System device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
|No Intervention: No device used|
|Sham Comparator: Device attached, not activated||
Device: Sham Air Barrier System device
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.
|Experimental: Device deployed and activated||
Device: Air Barrier System Device
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.
- Surgery Site CFU Density [ Time Frame: Ten minute intervals throughout surgery ]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.
- Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter [ Time Frame: Ten minute intervals throughout surgery ]Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size >10 micrometer had the strongest correlation to the presence of CFUs at the incision site.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972153
|United States, Texas|
|Texas Orthopedic Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gregory Stocks, MD||Fondren Orthopaedic Group|