Normal Paranasal Sinuses Microflora Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Arkadi Yakirevitch, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00426569
First received: January 23, 2007
Last updated: May 22, 2015
Last verified: May 2015
  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 Sheba Medical Center:

Primary Outcome Measures:
  • presence of bacteria in normal paranasal sinuses [ Time Frame: at time of orthgnatic surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 23, 2007
Last Updated: May 22, 2015
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on September 03, 2015