Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2016-12-31
2018-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
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.
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Need for interpreter
18 Years
80 Years
ALL
No
Sponsors
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Region Capital Denmark
OTHER
Kåre Håkansson
OTHER
Responsible Party
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Kåre Håkansson
MD, Ph.D
Principal Investigators
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Steffen Ørntoft, MD
Role: PRINCIPAL_INVESTIGATOR
Steffen Ørntoft, Ear, Nose and Throat specialist clinic
Locations
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Ørelæge Steffen Ørntoft
Hvidovre, , Denmark
Countries
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Other Identifiers
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CIV-16-04-015264
Identifier Type: -
Identifier Source: org_study_id
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