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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.
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 (e.g. bacteria colonies) and particulate at the surgery site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No device used | No Intervention | ||
| Device attached, not activated | Sham Comparator |
| |
| Device deployed and activated | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air Barrier System Device | Device | Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Stocks, MD | Fondren Orthopaedic Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Orthopedic Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19913327 | Background | 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. |
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Thirty-six patients of the surgeon who consented to undergo primary total hip arthroplasty between May and September 2009 were recruited to participate in this study. All consenting patients were eligible. Patients undergoing hemiarthroplasty, resurfacing, or revision arthroplasty were excluded from recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Device Used | |
| FG001 | Device Attached, Not Activated | |
| FG002 | Device Deployed and Activated |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Device Used | |
| BG001 | Device Attached, Not Activated | |
| BG002 | Device Deployed and Activated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Airborne CFU densities were obtained in ten-minute intervals throughout each procedure. Average surgery duration was 69 minutes in the control and sham groups; 66 minutes in the experiment group. A total of 208 density readings were obtained. | Posted | Median | Full Range | CFU/cubic meter | Ten minute intervals throughout surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Device Used |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Self | Nimbic Systems | 281-565-5715 | self@nimbicsystems.com |
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| Sham Air Barrier System device | 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. |
|
| Ten minute intervals throughout surgery |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Device Deployed and Activated |
|
|
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| Secondary | Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter | 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. | Posted | Median | Full Range | >10 micrometer particles / cubic meter | Ten minute intervals throughout surgery |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Device Attached, Not Activated | 0 | 0 | 0 | 0 |
| EG002 | Device Deployed and Activated | 0 | 0 | 0 | 0 |
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