Surgery
Conditions
Keywords
Decrease in CFU density at surgery site, Decrease in airborne particulate at surgery site
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.
Detailed description
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.
Interventions
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.
DEVICESham 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.
Sponsors
Nimbic Systems, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Candidate for primary total hip arthroplasty
Exclusion criteria
* Prior history of infection * Revision arthroplasty * Screens positive for MRSA * Undergoing hemiarthroplasty or resurfacing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Site CFU Density | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| No Device Used | 12 |
| Device Attached, Not Activated | 12 |
| Device Deployed and Activated | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Equipment malfunction during case | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | No Device Used | Device Attached, Not Activated | Device Deployed and Activated | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 8 Participants | 25 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 12 participants | 36 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Ten minute intervals throughout surgery
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Device Used | Surgery Site CFU Density | 7 CFU/cubic meter |
| Device Attached, Not Activated | Surgery Site CFU Density | 11 CFU/cubic meter |
| Device Deployed and Activated | Surgery Site CFU Density | 0 CFU/cubic meter |
Comparison: Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.p-value: <0.001t-test, 2 sided
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.
Time frame: Ten minute intervals throughout surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Device Used | Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter | 1377 >10 micrometer particles / cubic meter |
| Device Attached, Not Activated | Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter | 1165 >10 micrometer particles / cubic meter |
| Device Deployed and Activated | Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter | 247 >10 micrometer particles / cubic meter |
Comparison: Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.p-value: <0.001t-test, 2 sided