Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contamination Free Bacterial Swap

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924103
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Region Capital Denmark
Information provided by (Responsible Party):
Kåre Håkansson, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date April 11, 2018
Study Start Date  ICMJE December 2016
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contamination Free Bacterial Swap
Official Title  ICMJE Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Sinusitis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Right side

    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.

    Intervention: Device: Contamination free bacterial swab
  • Active Comparator: Left side
    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: Device: Contamination free bacterial swab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2018)
64
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
70
Actual Study Completion Date  ICMJE March 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • symptoms of upper airway disease

Exclusion Criteria:

  • mental illness
  • Need for interpreter
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02924103
Other Study ID Numbers  ICMJE CIV-16-04-015264
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kåre Håkansson, Rigshospitalet, Denmark
Study Sponsor  ICMJE Kåre Håkansson
Collaborators  ICMJE Region Capital Denmark
Investigators  ICMJE
Principal Investigator: Steffen Ørntoft, MD Steffen Ørntoft, Ear, Nose and Throat specialist clinic
PRS Account Rigshospitalet, Denmark
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP