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Air Barrier System for the Prevention of Prosthesis-related Infections

NCT02376153 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 816

Last updated 2018-09-06

No results posted yet for this 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.

Conditions

  • Prosthesis-Related Infections

Interventions

DEVICE

ABS deployed and active

ABS is deployed onto surgical field and is turned on.

DEVICE

ABS deployed and NOT active

ABS is deployed onto surgical field and is NOT turned on.

Sponsors & Collaborators

  • Nimbic Systems, LLC

    lead INDUSTRY

Principal Investigators

  • Sean Self · Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-24
Primary Completion
2019-08-31
Completion
2019-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376153 on ClinicalTrials.gov