Contamination Free Bacterial Swap

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924103
• Other study ID #: CIV-16-04-015264
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: April 10, 2018
• Start date: December 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: April 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• symptoms of upper airway disease

Exclusion Criteria:

• mental illness

• Need for interpreter

Related Conditions & MeSH terms

• Sinusitis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Ørelæge Steffen Ørntoft	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Kåre Håkansson	Region Capital Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of staphylococcus aureus positive cultures	Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose	1 year
Secondary	Frequency of other bacteria in cultures	Comparison of the frequency of other positive cultures from the two sides of the nose	1 year