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Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty

NCT03782675 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-12-20

No results posted yet for this study

Summary

The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.

Conditions

  • Osteo Arthritis Shoulders

Interventions

DEVICE

Control

The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator.

DEVICE

Air Barrier System

The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room.

Sponsors & Collaborators

  • Texas Orthopedic Hospital

    collaborator UNKNOWN

  • Nimbic Systems, LLC

    lead INDUSTRY

Principal Investigators

  • Gregory Stocks, MD · Texas Orthopedic Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-05-31
Completion
2019-07-31
FDA Device
Yes

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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 NCT03782675 on ClinicalTrials.gov