Device to Reduce Surgery Site Contamination

• Sponsor: Nimbic Systems, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00972153
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Device: Air Barrier System Device; Device: Sham Air Barrier System device	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• 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 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Orthopedic Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Nimbic Systems, LLC

Investigators

• Principal Investigator: Gregory Stocks, MD, Fondren Orthopaedic Group

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Nimbic Systems, LLC
• ClinicalTrials.gov Identifier: NCT00972153
• Other Study ID Numbers: ABS001-0912403
• First Posted: Sep 4, 2009
• Last Update Posted: Mar 16, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Nimbic Systems, LLC: Decrease in CFU density at surgery site; Decrease in airborne particulate at surgery site

Study Results

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.

Arm/Group Title	No Device Used	Device Attached, Not Activated	Device Deployed and Activated
Arm/Group Description
Period Title: Overall Study
STARTED	12	12	12
COMPLETED	12	11	12
NOT COMPLETED	0	1	0

Baseline Characteristics

Arm/Group Title	No Device Used	Device Attached, Not Activated	Device Deployed and Activated	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	12	12	12	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	8 66.7%	9 75%	8 66.7%	25 69.4%
>=65 years	4 33.3%	3 25%	4 33.3%	11 30.6%
Sex: Female, Male (Count of Participants)
Female	7 58.3%	6 50%	7 58.3%	20 55.6%
Male	5 41.7%	6 50%	5 41.7%	16 44.4%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	12 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Surgery Site CFU Density
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	12	11	12
Median (Full Range) [CFU/cubic meter]	7	11	0

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Device Used	Device Attached, Not Activated	Device Deployed and Activated
Arm/Group Description
Measure Participants	12	11	12
Median (Full Range) [>10 micrometer particles / cubic meter]	1377	1165	247

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	No Device Used		Device Attached, Not Activated		Device Deployed and Activated
Arm/Group Description
All Cause Mortality
	No Device Used		Device Attached, Not Activated		Device Deployed and Activated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	No Device Used		Device Attached, Not Activated		Device Deployed and Activated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	No Device Used		Device Attached, Not Activated		Device Deployed and Activated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

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.