Device to Reduce Surgery Site Contamination

March 14, 2012 updated by: Nimbic Systems, LLC

Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow

The objective of this study is to determine whether the Air Barrier System device reduces airborne particulate and airborne colony forming units present at a surgery site.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Air Barrier System 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 Air Barrier System can reduce the presence of airborne colony-forming units (e.g. bacteria colonies) and particulate at the surgery site.

Study Type

Interventional

Enrollment (Actual)

29

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.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Orthopedic Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidate for primary total hip arthroplasty

Exclusion Criteria:

  • Prior history of infection
  • Revision arthroplasty
  • Screens positive for MRSA
  • Undergoing hemiarthroplasty or resurfacing

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No device used
Sham Comparator: Device attached, not activated
Device: Sham Air Barrier System device
Device is deployed to the surgery site, but the airflow is not activated. This intervention is used to determine any effects that the presence of the device alone may have.
Experimental: Device deployed and activated
Device: Air Barrier System Device
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery Site CFU Density
Time Frame: Ten minute intervals throughout surgery
Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol "slit" sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter.
Ten minute intervals throughout surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter
Time Frame: Ten minute intervals throughout surgery
Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size >10 micrometer had the strongest correlation to the presence of CFUs at the incision site.
Ten minute intervals throughout surgery

Collaborators and Investigators

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

Sponsor

Nimbic Systems, LLC

Investigators

  • Principal Investigator: Gregory Stocks, MD, Fondren Orthopaedic Group

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

May 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ABS001-0912403

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.

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