SurgeryNCT00972153
Device to Reduce Surgery Site Contamination
A study testing Air Barrier System Device in people with Surgery, run by Nimbic Systems, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- Air Barrier System Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidate for primary total hip arthroplasty
Who cannot join
- Prior history of infection
- Revision arthroplasty
- Screens positive for MRSA
- Undergoing hemiarthroplasty or resurfacing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Air Barrier System Device, Sham Air Barrier System device
- Keywords
- Decrease in CFU density at surgery site, Decrease in airborne particulate at surgery site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Barrier System DeviceDevice
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.
Sham Air Barrier System deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| No device used | No intervention | Not described |
| Device attached, not activated | Sham comparator | Not described Receives: Device: Sham Air Barrier System device |
| Device deployed and activated | Experimental | Not described Receives: Device: Air Barrier System Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ten minute intervals throughout surgery
Secondary outcomes (1)
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.
Measured: Ten minute intervals throughout surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nimbic Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Stocks, MD, Principal investigator, Fondren Orthopaedic Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972153
- Sponsor's protocol ID
- ABS001-0912403
- Status last verified
- Mar 2012
- First submitted
- 2 Sep 2009
- Last updated
- 16 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 19913327
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow
- ClinicalTrials.gov ID
- NCT00972153
- Acronym / sponsor ID
- ABS001-0912403
- Conditions
- Surgery
- Keywords
- Decrease in CFU density at surgery site, Decrease in airborne particulate at surgery site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Nimbic Systems, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Posted 18 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No device used | No intervention | – |
| Device attached, not activated | Sham comparator | Device: Sham Air Barrier System device |
| Device deployed and activated | Experimental | Device: Air Barrier System Device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Candidate for primary total hip arthroplasty
Key exclusion criteria (4 listed)
- Prior history of infection
- Revision arthroplasty
- Screens positive for MRSA
- Undergoing hemiarthroplasty or resurfacing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Barrier System DeviceDevice is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site. | Device | Device deployed and activated |
| Sham Air Barrier System deviceDevice 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. | Device | Device attached, not activated |
Primary outcome
Surgery Site CFU Density
Time frame: 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.
1 secondary outcome
Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter
Time frame: Ten minute intervals throughout surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19913327Stocks 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Stocks, MD principal investigator
Fondren Orthopaedic Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Barrier System Device in people with Surgery, run by Nimbic Systems, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery Site CFU Density (time frame: Ten minute intervals throughout surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.