Osteo Arthritis ShouldersNCT03782675
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
A study testing Air Barrier System in people with Osteo Arthritis Shoulders, run by Nimbic Systems, LLC.
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 total shoulder arthroplasty surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Shoulders
- What is being tested?
- Air Barrier System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for total shoulder arthroplasty
Who cannot join
- Prior history of infection
- Revision surgery
- Screens positive for MRSA
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.
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 total shoulder arthroplasty surgeries.
Read the detailed description
The Air Barrier System (ABS) 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 ABS can reduce the presence of airborne CFU and particles at the surgery site during total arthroplasty surgery.
- Conditions
- Osteo Arthritis Shoulders
- Being tested
- Control, Air Barrier System
- Keywords
- Total shoulder replacement, operating room air, surgical site infection, airborne CFU
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDevice
The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator.
Air Barrier SystemDevice
The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | In the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device the device is turned on or not. Receives: Device: Control |
| Air Barrier System | Experimental | In the experimental (interventional) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not. Receives: Device: Air Barrier System |
What is being measured
The primary outcome is the main question the study is designed to answer.
CFU counts
Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
Measured: Four months
Particle counts
Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study startFeb 2019 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis ShouldersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimbic Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas Orthopedic Hospital
- Responsible party
- Sponsor
- Investigators
- Gregory Stocks, MD, Principal investigator, Texas Orthopedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782675
- Sponsor's protocol ID
- ABS-104
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.
- ClinicalTrials.gov ID
- NCT03782675
- Acronym / sponsor ID
- ABS-104
- Conditions
- Osteo Arthritis Shoulders
- Keywords
- Total shoulder replacement, operating room air, surgical site infection, airborne CFU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nimbic Systems, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Texas Orthopedic Hospital
- Study start
- Feb 2019 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
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 total shoulder arthroplasty surgeries.
Detailed description
The Air Barrier System (ABS) 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 ABS can reduce the presence of airborne CFU and particles at the surgery site during total arthroplasty surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: ControlIn the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device the device is turned on or not. |
| Air Barrier System | Experimental | Device: Air Barrier SystemIn the experimental (interventional) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidate for total shoulder arthroplasty
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 |
|---|---|---|
| ControlThe Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator. | Device | Control |
| Air Barrier SystemThe Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room. | Device | Air Barrier System |
Primary outcome
CFU counts
Time frame: Four months
Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
Particle counts
Time frame: Four months
Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- 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.
- Individual participant dataSharing planned: No
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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
Texas Orthopedic Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Air Barrier System in people with Osteo Arthritis Shoulders, run by Nimbic Systems, LLC.
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: status not confirmed, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory Stocks, MD (713-799-8600, stocks@fondren.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CFU counts (time frame: Four months). The study lists 2 primary outcomes in all. 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 NCT03782675, 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 20 Dec 2018.