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Normal Paranasal Sinuses Microflora Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426569
First Posted: January 24, 2007
Last Update Posted: May 25, 2015
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.
Information provided by (Responsible Party):
Dr. Arkadi Yakirevitch, Sheba Medical Center
  Purpose

The purpose of this study is to check if bacterial and fungal flora exists in healthy paranasal sinuses, and whether it is identical to the flora of nasal cavity.

We plan to harvest tiny examples of maxillary sinus and nasal mucosa for tissue cultures during the orthognathic procedures involving maxillary remodeling.


Condition
Paranasal Sinuses Flora

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Dr. Arkadi Yakirevitch, Sheba Medical Center:

Primary Outcome Measures:
  • presence of bacteria in normal paranasal sinuses [ Time Frame: at time of orthgnatic surgery ]

Enrollment: 18
Study Start Date: February 2007
Study Completion Date: May 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Healthy adults undergoing orthognatic procedure
Criteria

Inclusion Criteria:

  • Necessity of maxillary sinus opening during orthognathic surgery
  • Negative history of chronic rhinitis or chronic sinusitis
  • Informed concent

Exclusion Criteria:

  • Recent(1 month or less before the operation) event of acute sinusitis or other disease leading to nasal discharge
  • Recent(1 month or less before the operation) antibacterial or antifungal parenteral treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426569


Locations
Israel
Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arkadi Yakirevitch, M.D. Department of Otorhinolaryngology-Head and Neck Surgery, Sheba Medical Center, Israel
  More Information

Responsible Party: Dr. Arkadi Yakirevitch, Arkadi Yakirevitch, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00426569     History of Changes
Other Study ID Numbers: SHEBA-07-4534-AY-CTIL
First Submitted: January 23, 2007
First Posted: January 24, 2007
Last Update Posted: May 25, 2015
Last Verified: May 2015


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