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

December 19, 2018 updated by: Nimbic Systems, LLC

Air Barrier System for the Reduction of Airborne Particulate and Colony-forming Units (CFU) During Total Shoulder Arthroplasty.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU and particles at the surgery site during total arthroplasty surgery.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidate for total shoulder arthroplasty

Exclusion Criteria:

  • Prior history of infection
  • Revision surgery
  • Screens positive for MRSA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control
In the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device the device is turned on or not.
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.
EXPERIMENTAL: Air Barrier System
In the experimental (interventional) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CFU counts
Time Frame: Four months
Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
Four months
Particle counts
Time Frame: Four months
Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nimbic Systems, LLC

Collaborators

Texas Orthopedic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2019

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (ACTUAL)

December 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABS-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteo Arthritis Shoulders

Clinical Trials on Air Barrier System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe