An interventional study of Contamination free bacterial swab in Sinusitis, sponsored by Kåre Håkansson. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by Kåre Håkansson · Not applicable, Interventional, and Diagnostic
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.
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.
417 studies on the registry are indexed under Sinusitis; 47 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 314 interventional studies indexed under Sinusitis.
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Exclusion Criteria:
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
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.
Frequency of staphylococcus aureus positive cultures
Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose
Time frame: 1 year
Frequency of other bacteria in cultures
Comparison of the frequency of other positive cultures from the two sides of the nose
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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