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Device

ABS deployed and active for Prosthesis Infections

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
Awards & highlights

Study 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.

Eligible Conditions
  • Prosthesis Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-year post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and one-year post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Air Barrier System for the Prevention of Prosthesis-related Infections
2015. "Air Barrier System for the Prevention of Prosthesis-related Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02376153.
All > Rsv
~82 spots leftby Apr 2025
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