Contamination Free Bacterial Swap

Kåre Håkansson

Status: Completed

Conditions: Sinusitis

Treatments: Device: Contamination free bacterial swab

Study type: Interventional

Funder types: Other

Identifiers

NCT02924103

CIV-16-04-015264

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptoms of upper airway disease

Exclusion criteria

• mental illness
• Need for interpreter

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Right side

Active Comparator group

Description:

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.

Treatment:

Device: Contamination free bacterial swab

Left side

Active Comparator group

Description:

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).

Treatment:

Device: Contamination free bacterial swab