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Normal Paranasal Sinuses Microflora Study

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ClinicalTrials.gov Identifier: NCT00426569
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Paranasal Sinuses Flora

Study Design

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : February 2007
Primary Completion Date : April 2015
Study Completion Date : May 2015
Groups and Cohorts


Outcome Measures

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

Eligibility Criteria

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 Posted: January 24, 2007    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015