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Contamination Free Bacterial Swap

Primary Purpose

Sinusitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Contamination free bacterial swab
Sponsored by
Kåre Håkansson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sinusitis focused on measuring acute rhinosinusitis, staphylococcus aureus, nasal vestibule, contamination

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptoms of upper airway disease

Exclusion Criteria:

  • mental illness
  • Need for interpreter

Sites / Locations

  • Ørelæge Steffen Ørntoft

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Right side

Left side

Arm 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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of other bacteria in cultures
Comparison of the frequency of other positive cultures from the two sides of the nose

Full Information

First Posted
June 6, 2016
Last Updated
April 10, 2018
Sponsor
Kåre Håkansson
Collaborators
Region Capital Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02924103
Brief Title
Contamination Free Bacterial Swap
Official Title
Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kåre Håkansson
Collaborators
Region Capital Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
acute rhinosinusitis, staphylococcus aureus, nasal vestibule, contamination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right side
Arm Type
Active Comparator
Arm 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.
Arm Title
Left side
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Contamination free bacterial swab
Intervention Description
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 Outcome Measure Information:
Title
Frequency of staphylococcus aureus positive cultures
Description
Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frequency of other bacteria in cultures
Description
Comparison of the frequency of other positive cultures from the two sides of the nose
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptoms of upper airway disease Exclusion Criteria: mental illness Need for interpreter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Ørntoft, MD
Organizational Affiliation
Steffen Ørntoft, Ear, Nose and Throat specialist clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ørelæge Steffen Ørntoft
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Contamination Free Bacterial Swap

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