NCT02924103

Contamination Free Bacterial Swap

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Kåre Håkansson · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Sinusitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-10-05
• Last updated: 2018-04-11

Locations

1 site across 1 country: Denmark