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Completed

NCT Number: NCT02924103

Contamination Free Bacterial Swap

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.

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Key information

Conditions

Sinusitis Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Staphylococcal Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ørelæge Steffen Ørntoft

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptoms of upper airway disease

Exclusion criteria

  • mental illness
  • Need for interpreter

Treatment and study plan

Contamination free bacterial swab

Device

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.

Primary outcomes

  1. Frequency of staphylococcus aureus positive cultures

    Time frame: 1 year

    Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose

Secondary outcomes

  1. Frequency of other bacteria in cultures

    Time frame: 1 year

    Comparison of the frequency of other positive cultures from the two sides of the nose

Sponsors and collaborators

Lead sponsor

Kåre Håkansson

Other

Collaborators

  • Region Capital Denmark

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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