Air Barrier System for the Prevention of Prosthesis-related 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

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

CIED 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

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

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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