SurgeryNCT01262105
Device to Reduce Surgery Site Contamination - Spine
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 colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures. 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?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- 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 instrumented posterior lumbar interbody fusion
Who cannot join
- Prior history of infection
- Revision surgery
- Screens positive for MRSA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.
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 at the surgery site during spinal procedures.
- Conditions
- Surgery
- Being tested
- Air Barrier System Device
- Keywords
- CFU, 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 site.
| Study group | Role | What they receive |
|---|---|---|
| No device | No intervention | Not described |
| Device deployed | 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
CFU culture counts for samples taken in surgery.
Measured: Ten-minute intervals throughout procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionDec 2010
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nimbic Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wimberley, MD, Principal investigator, Fondren Orthopaedic Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262105
- Sponsor's protocol ID
- ABS-002
- Status last verified
- Apr 2012
- First submitted
- 15 Dec 2010
- Last updated
- 11 Apr 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 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow
- ClinicalTrials.gov ID
- NCT01262105
- Acronym / sponsor ID
- ABS-002
- Conditions
- Surgery
- Keywords
- CFU, surgery site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nimbic Systems, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 9 Apr 2012
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 colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.
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 at the surgery site during spinal procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No device | No intervention | – |
| Device deployed | 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 instrumented posterior lumbar interbody fusion
Key exclusion criteria (3 listed)
- Prior history of infection
- Revision surgery
- Screens positive for MRSA
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 site. | Device | Device deployed |
Primary outcome
Surgery Site CFU Density
Time frame: Ten-minute intervals throughout procedure
CFU culture counts for samples taken in surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
David Wimberley, 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 3 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 11 Apr 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. 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 9 Apr 2012). 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 procedure). 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 NCT01262105, 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 11 Apr 2012.