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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
Sponsor:
Information provided by (Responsible Party):
Nimbic Systems, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Surgery
Interventions Device: Air Barrier System Device
Device: Sham Air Barrier System device
Enrollment 29
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.
Pre-assignment Details  
Arm/Group Title No Device Used Device Attached, Not Activated Device Deployed and Activated
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 12 12 12
Completed 12 11 [1] 12
Not Completed 0 1 0
Reason Not Completed
Equipment malfunction during case             0             1             0
[1]
One case excluded due to technical problem with measuring equipment.
Arm/Group Title No Device Used Device Attached, Not Activated Device Deployed and Activated Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  66.7%
9
  75.0%
8
  66.7%
25
  69.4%
>=65 years
4
  33.3%
3
  25.0%
4
  33.3%
11
  30.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 36 participants
Female
7
  58.3%
6
  50.0%
7
  58.3%
20
  55.6%
Male
5
  41.7%
6
  50.0%
5
  41.7%
16
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 12 participants 36 participants
12 12 12 36
1.Primary Outcome
Title Surgery Site CFU Density
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title No Device Used Device Attached, Not Activated Device Deployed and Activated
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 11 12
Median (Full Range)
Unit of Measure: CFU/cubic meter
7
(0 to 36)
11
(0 to 46)
0
(0 to 14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Device Used, Device Attached, Not Activated, Device Deployed and Activated
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Device Used Device Attached, Not Activated Device Deployed and Activated
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 11 12
Median (Full Range)
Unit of Measure: >10 micrometer particles / cubic meter
1377
(459 to 8746)
1165
(424 to 5474)
247
(0 to 5968)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Device Used, Device Attached, Not Activated, Device Deployed and Activated
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Device Used Device Attached, Not Activated Device Deployed and Activated
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
No Device Used Device Attached, Not Activated Device Deployed and Activated
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
No Device Used Device Attached, Not Activated Device Deployed and Activated
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
No Device Used Device Attached, Not Activated Device Deployed and Activated
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sean Self
Organization: Nimbic Systems
Phone: 281-565-5715
EMail: self@nimbicsystems.com
Layout table for additonal information
Responsible Party: Nimbic Systems, LLC
ClinicalTrials.gov Identifier: NCT00972153    
Other Study ID Numbers: ABS001-0912403
First Submitted: September 2, 2009
First Posted: September 4, 2009
Results First Submitted: April 22, 2010
Results First Posted: May 18, 2010
Last Update Posted: March 16, 2012