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Device
ABS deployed and active for Central Line Infection
N/A
Waitlist Available
Led By Sean Self
Research Sponsored by Nimbic Systems, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-year post surgery
Summary
This trial is testing a new device called the Air Barrier System (ABS) that creates a clean air bubble around surgical cuts to keep germs out. It targets patients having hip replacements, acetabular repairs, spinal fusions, and vascular graft surgeries. The goal is to see if this device can reduce the risk of infections after these surgeries.
Eligible Conditions
- Central Line Infection
- Prosthesis Infections
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one-year post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-year post surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical incidence of surgical site infection
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ABS deployed and activeExperimental Treatment1 Intervention
Air Barrier System (ABS) will be deployed onto the surgical field and activated.
Group II: ABS deployed and NOT activePlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Nimbic Systems, LLCLead Sponsor
6 Previous Clinical Trials
473 Total Patients Enrolled
Sean SelfPrincipal InvestigatorInvestigator
1 Previous Clinical Trials
41 Total Patients Enrolled
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