Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
1 other identifier
interventional
40
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedDecember 20, 2018
December 1, 2018
3 months
December 13, 2018
December 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
CFU counts
Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm
Four months
Particle counts
Inter-arm comparison of particle counts taken during both the Control arm and ABS arm.
Four months
Study Arms (2)
Control
SHAM COMPARATORIn 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.
Air Barrier System
EXPERIMENTALIn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Candidate for total shoulder arthroplasty
You may not qualify if:
- Prior history of infection
- Revision surgery
- Screens positive for MRSA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nimbic Systems, LLClead
- Texas Orthopedic Hospitalcollaborator
Related Publications (1)
Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.
PMID: 19913327BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Stocks, MD
Texas Orthopedic Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 20, 2018
Study Start
February 1, 2019
Primary Completion
May 1, 2019
Study Completion
July 1, 2019
Last Updated
December 20, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share