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Normal Paranasal Sinuses Microflora Study

This study has been completed.
Information provided by (Responsible Party):
Dr. Arkadi Yakirevitch, Sheba Medical Center Identifier:
First received: January 23, 2007
Last updated: May 22, 2015
Last verified: May 2015

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.

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)

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

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
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Please refer to this study by its identifier: NCT00426569

Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
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 Identifier: NCT00426569     History of Changes
Other Study ID Numbers: SHEBA-07-4534-AY-CTIL
Study First Received: January 23, 2007
Last Updated: May 22, 2015 processed this record on July 24, 2017