Prosthesis-Related InfectionsNCT02376153
Air Barrier System for the Prevention of Prosthesis-related Infections
A study testing ABS deployed and active and ABS deployed and NOT active in people with Prosthesis-Related Infections, run by Nimbic Systems, LLC at 1 site in United States.
Trial summary
This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Prosthesis-Related Infections
- What is being tested?
- ABS deployed and active and ABS deployed and NOT active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 816 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2015to Oct 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total hip arthroplasty;
- Acetabular repair with instrumentation;
- Posterior lumbar, cervical, or thoracic (up to and including 6 vertebral levels) spine fusion with instrumentation and vascular prosthetic graft implantation.
Who cannot join
- History of prior prosthesis infection;
- Active infection;
- Open traumatic wounds as is the case after some acetabular fractures.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Colleen C Stewart, MSN, 713-794-7127, Colleen.Cerra-Stewart@va.gov
Rabih O Darouiche, MD
About this study
This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.
Read the detailed description
This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis-related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision.
This research will evaluate ABS performance in a prospective, randomized, blinded multi-center trial. The surgical procedures studied will include total hip arthroplasty, trauma-related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic vascular graft procedures. Patients will be enrolled during the first two years of the study, and CDC guidelines require a one year follow-up period to monitor patients for potential prosthesis-related infections.
- Conditions
- Prosthesis-Related Infections
- Being tested
- ABS deployed and active, ABS deployed and NOT active
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABS deployed and activeDevice
ABS is deployed onto surgical field and is turned on.
ABS deployed and NOT activeDevice
ABS is deployed onto surgical field and is NOT turned on.
| Study group | Role | What they receive |
|---|---|---|
| ABS deployed and active | Experimental | Air Barrier System (ABS) will be deployed onto the surgical field and activated. Receives: Device: ABS deployed and active |
| ABS deployed and NOT active | Sham comparator | Air Barrier System (ABS) will be deployed onto the surgical field and NOT activated. This is a sham comparator to reduce the influence of the presence of the device and provide user blinding. Receives: Device: ABS deployed and NOT active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical incidence of surgical site infection
Subjects are followed for one year post-surgery for onset of prosthesis-related infections .
Measured: One-year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start24 Apr 2015
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis-Related InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 816 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimbic Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Self, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376153
- Sponsor's protocol ID
- ABS004-H-35894
- Status last verified
- Sep 2018
- First submitted
- 25 Feb 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no current plan.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Barrier System for the Prevention of Prosthesis-related Infections
- ClinicalTrials.gov ID
- NCT02376153
- Acronym / sponsor ID
- ABS004-H-35894
- Conditions
- Prosthesis-Related Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 816 participants (estimated)
- Lead sponsor
- Nimbic Systems, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2015 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 3 Mar 2015 (estimated)
- 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.
This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.
Detailed description
This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis-related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision.
This research will evaluate ABS performance in a prospective, randomized, blinded multi-center trial. The surgical procedures studied will include total hip arthroplasty, trauma-related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic vascular graft procedures. Patients will be enrolled during the first two years of the study, and CDC guidelines require a one year follow-up period to monitor patients for potential prosthesis-related infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABS deployed and active | Experimental | Device: ABS deployed and activeAir Barrier System (ABS) will be deployed onto the surgical field and activated. |
| ABS deployed and NOT active | Sham comparator | Device: ABS deployed and NOT activeAir Barrier System (ABS) will be deployed onto the surgical field and NOT activated. This is a sham comparator to reduce the influence of the presence of the device and provide user blinding. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total hip arthroplasty;
- Acetabular repair with instrumentation;
- Posterior lumbar, cervical, or thoracic (up to and including 6 vertebral levels) spine fusion with instrumentation and vascular prosthetic graft implantation.
Key exclusion criteria (3 listed)
- History of prior prosthesis infection;
- Active infection;
- Open traumatic wounds as is the case after some acetabular fractures.
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 |
|---|---|---|
| ABS deployed and activeABS is deployed onto surgical field and is turned on. | Device | ABS deployed and active |
| ABS deployed and NOT activeABS is deployed onto surgical field and is NOT turned on. | Device | ABS deployed and NOT active |
Primary outcome
Clinical incidence of surgical site infection
Time frame: One-year post surgery
Subjects are followed for one year post-surgery for onset of prosthesis-related infections .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No. There is no current plan.
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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.
Sean Self principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABS deployed and active and ABS deployed and NOT active in people with Prosthesis-Related Infections, 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 3 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 6 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean Self (281-565-5715, self@nimbicsystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical incidence of surgical site infection (time frame: One-year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2018.