Contamination Free Bacterial Swap

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Device: Contamination free bacterial swab

• Registration Number: NCT02924103
• Lead Sponsor: Kåre Håkansson

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Study Start: 2016-12
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• symptoms of upper airway disease

Exclusion Criteria

• mental illness
• Need for interpreter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left side	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).
Right side	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 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.

Primary Outcome Measures

Name	Time	Method
Frequency of staphylococcus aureus positive cultures	1 year	Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose

Secondary Outcome Measures

Name	Time	Method
Frequency of other bacteria in cultures	1 year	Comparison of the frequency of other positive cultures from the two sides of the nose

Trial Locations

Locations (1)

Ørelæge Steffen Ørntoft; 🇩🇰 Hvidovre, Denmark