Contamination Free Bacterial Swap

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02924103

Enrollment

Registered

2016-10-05

Start date

2016-12-31

Completion date

2018-03-01

Last updated

2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Keywords

acute rhinosinusitis, staphylococcus aureus, nasal vestibule, contamination

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.

Interventions

DEVICEContamination 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* symptoms of upper airway disease

Exclusion criteria

* mental illness * Need for interpreter

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Frequency of other bacteria in cultures	1 year	Comparison of the frequency of other positive cultures from the two sides of the nose

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026