Contamination Free Bacterial Swap

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)

Conditions
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Sinusitis

Intervention / Treatment
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* Device: Contamination free bacterial swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptoms of upper airway disease Exclusion Criteria: mental illness Need for interpreter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Right side<br>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<br>* 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.<br>|
| Active Comparator: Left side<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of staphylococcus aureus positive cultures | Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of other bacteria in cultures | Comparison of the frequency of other positive cultures from the two sides of the nose | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute rhinosinusitis, staphylococcus aureus, nasal vestibule, contamination