- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02376153
Air Barrier System for the Prevention of Prosthesis-related Infections
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sean Self
- Phone Number: 281-565-5715
- Email: self@nimbicsystems.com
Study Contact Backup
- Name: Kylie Pflieger
- Phone Number: 281-565-5701
- Email: k.pflieger@nimbicsystems.com
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Michael E. DeBakey VA Medical Center
-
Contact:
- Colleen C Stewart, MSN
- Phone Number: 713-794-7127
- Email: Colleen.Cerra-Stewart@va.gov
-
Principal Investigator:
- Rabih O Darouiche, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of prior prosthesis infection;
- Active infection;
- Open traumatic wounds as is the case after some acetabular fractures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABS deployed and active
Air Barrier System (ABS) will be deployed onto the surgical field and activated.
|
ABS is deployed onto surgical field and is turned on.
|
Sham Comparator: ABS deployed and NOT active
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.
|
ABS is deployed onto surgical field and is NOT turned on.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 .
|
One-year post surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sean Self, Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABS004-H-35894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prosthesis-Related Infections
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BioMed Valley Discoveries, IncCompleted
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Tourcoing HospitalCompletedProsthesis-related InfectionsFrance
-
University Hospital, ToursCompletedProsthesis-related InfectionsFrance
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Pro-Implant FoundationCharite University, Berlin, GermanyUnknownProsthesis-related InfectionsGermany
-
Oslo University HospitalUnknownStaphylococcal Infections | Prosthesis-related InfectionsNorway
-
The Cleveland Clinic3MCompletedJoint Diseases | Musculoskeletal Diseases | Prosthesis-related Infections | Wound ComplicationsUnited States
-
University Hospital, Strasbourg, FranceRecruitingProsthesis Related InfectionFrance
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedProstheses-related Infections
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University Hospital of FerraraCompletedDevice Related Infection
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Rush University Medical CenterCompletedProsthesis-Related InfectionsUnited States
Clinical Trials on ABS deployed and active
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Assiut UniversityUnknownAntiphospholipid Antibodies & Osteopontin as Risk Factors for Cerebrovascular Stroke in Young AdultsStroke in Young AdultsEgypt
-
Acibadem UniversityUnknownHematoma | Radial Artery Injury | BleedTurkey
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Hospices Civils de LyonActive, not recruiting
-
University of PadovaCompletedDepression | Quality of Life | Anxiety | Stress, Emotional | Coping SkillsItaly
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Unilever R&DCompleted
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Centre Hospitalier Universitaire DijonUnknownType 2 Diabetes or Obesity Without DiabetesFrance
-
Chang Gung Memorial HospitalEnrolling by invitationSuspected Non-Alzheimer Disease Pathophysiology (SNAP)Taiwan
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University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedExcessive Physical Exercise, UnspecifiedBrazil
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University of East AngliaUniversity of Hertfordshire; Hertfordshire Sports Partnership; Sport England; Broxbourne... and other collaboratorsUnknown
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University of North Texas Health Science CenterNational Institutes of Health (NIH); National Center for Complementary and... and other collaboratorsCompletedLow Back PainUnited States