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Contamination Free Bacterial Swap

This study is currently recruiting participants.
Verified September 2017 by Kåre Håkansson, Rigshospitalet, Denmark
Sponsor:
ClinicalTrials.gov Identifier:
NCT02924103
First Posted: October 5, 2016
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Region Capital Denmark
Information provided by (Responsible Party):
Kåre Håkansson, Rigshospitalet, Denmark
  Purpose
A test of a newly designed device (Contamination free bacterial swab). This device can be used to introduce a standard bacterial swab into the nose without direct or indirect contact with the nasal vestibule.

Condition Intervention
Sinusitis Device: Contamination free bacterial swab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)

Resource links provided by NLM:


Further study details as provided by Kåre Håkansson, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Frequency of staphylococcus aureus positive cultures [ Time Frame: 1 year ]
    Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose


Secondary Outcome Measures:
  • Frequency of other bacteria in cultures [ Time Frame: 1 year ]
    Comparison of the frequency of other positive cultures from the two sides of the nose


Estimated Enrollment: 70
Study Start Date: December 2016
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Right side

All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy), will be introduced to both sides of the nose (to the middle meatus); on the RIGHT side by using the "Contamination free bacterial swab" introduction device.

The "Contamination free bacterial swab" introduction device is a prototype developed for clinical testing.

Device: Contamination free bacterial swab
A comparison of the bacteriology in bacterial swabs (Eswab 481CE, Copan Diagnostics, Italy) from the middle meatus. On the RIGHT side using the "Contamination free bacterial swab" introduction device that facilitates the introduction of a bacterial swab into the nose without direct or indirect contact with the nasal vestibule.
Active Comparator: Left side
All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy) will be introduced to both sides of the nose (to the middle meatus); on the LEFT side using the present day clinical procedure (visually guided introduction).
Device: Contamination free bacterial swab
A comparison of the bacteriology in bacterial swabs (Eswab 481CE, Copan Diagnostics, Italy) from the middle meatus. On the RIGHT side using the "Contamination free bacterial swab" introduction device that facilitates the introduction of a bacterial swab into the nose without direct or indirect contact with the nasal vestibule.

Detailed Description:

Aim:

The investigators want to improved the current method for bacterial culture test in patients with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The investigators will examine whether significantly fewer Staphylococcus Aureus are detected in the middle meatus when applying a new device for bacterial swab introduction. This device is designed to prevent bacterial pollution from the nasal vestibule.

More precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in nasal swabs from 10-15 % to 0-5 %.

The overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients with sino-nasal disease.

Design:

A comparative study in which patients serve as their own control. A bacterial swab will be introduced to both sides of the nose; on the right side using the new device, on the left side using the present day technique (visual guidance). 70 participants will be included.

Statistics:

A chi-square test will be used for comparison of frequencies.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptoms of upper airway disease

Exclusion Criteria:

  • mental illness
  • Need for interpreter
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924103


Contacts
Contact: Kåre Håkansson, MD, Ph.D +45 28262589 k.haakansson@gmail.com

Locations
Denmark
Ørelæge Steffen Ørntoft Recruiting
Hvidovre, Denmark, 2650
Contact: Steffen Ørntoft, MD    36 78 88 03    steffens.klinik@gmail.com   
Sponsors and Collaborators
Kåre Håkansson
Region Capital Denmark
Investigators
Principal Investigator: Steffen Ørntoft, MD Steffen Ørntoft, Ear, Nose and Throat specialist clinic
  More Information

Responsible Party: Kåre Håkansson, MD, Ph.D, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02924103     History of Changes
Other Study ID Numbers: CIV-16-04-015264
First Submitted: June 6, 2016
First Posted: October 5, 2016
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kåre Håkansson, Rigshospitalet, Denmark:
acute rhinosinusitis
staphylococcus aureus
nasal vestibule
contamination

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases