Trial Outcomes & Findings for Device to Reduce Surgery Site Contamination (NCT NCT00972153)
NCT ID: NCT00972153
Last Updated: 2012-03-16
Results Overview
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.
COMPLETED
NA
29 participants
Ten minute intervals throughout surgery
2012-03-16
Participant Flow
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.
Participant milestones
| Measure |
No Device Used
|
Device Attached, Not Activated
|
Device Deployed and Activated
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
No Device Used
|
Device Attached, Not Activated
|
Device Deployed and Activated
|
|---|---|---|---|
|
Overall Study
Equipment malfunction during case
|
0
|
1
|
0
|
Baseline Characteristics
Device to Reduce Surgery Site Contamination
Baseline characteristics by cohort
| Measure |
No Device Used
n=12 Participants
|
Device Attached, Not Activated
n=12 Participants
|
Device Deployed and Activated
n=12 Participants
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
12 participants
n=41 Participants
|
12 participants
n=35 Participants
|
36 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Ten minute intervals throughout surgeryPopulation: 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.
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.
Outcome measures
| Measure |
No Device Used
n=12 Participants
|
Device Attached, Not Activated
n=11 Participants
|
Device Deployed and Activated
n=12 Participants
|
|---|---|---|---|
|
Surgery Site CFU Density
|
7 CFU/cubic meter
Interval 0.0 to 36.0
|
11 CFU/cubic meter
Interval 0.0 to 46.0
|
0 CFU/cubic meter
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: Ten minute intervals throughout surgeryAirborne 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.
Outcome measures
| Measure |
No Device Used
n=12 Participants
|
Device Attached, Not Activated
n=11 Participants
|
Device Deployed and Activated
n=12 Participants
|
|---|---|---|---|
|
Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter
|
1377 >10 micrometer particles / cubic meter
Interval 459.0 to 8746.0
|
1165 >10 micrometer particles / cubic meter
Interval 424.0 to 5474.0
|
247 >10 micrometer particles / cubic meter
Interval 0.0 to 5968.0
|
Adverse Events
No Device Used
Device Attached, Not Activated
Device Deployed and Activated
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place