Normal Paranasal Sinuses Microflora Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Sheba Medical Center.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Dr. Arkadi Yakirevitch, Sheba Medical Center
First received: January 23, 2007
Last updated: December 17, 2012
Last verified: December 2012
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.
||Observational Model: Case-Only
Time Perspective: Prospective
Primary Outcome Measures:
- presence of bacteria in normal paranasal sinuses [ Time Frame: at time of orthgnatic surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Healthy adults undergoing orthognatic procedure
- Necessity of maxillary sinus opening during orthognathic surgery
- Negative history of chronic rhinitis or chronic sinusitis
- Informed concent
- 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
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
|Sheba Medical Center
|Tel Hashomer, Israel, 52621 |
|Contact: Lev Bedrin, MD, PhD 972526667254 |
|Principal Investigator: Arkadi Yakirevitch, MD |
Sheba Medical Center
||Arkadi Yakirevitch, M.D.
||Department of Otorhinolaryngology-Head and Neck Surgery, Sheba Medical Center, Israel
No publications provided
ClinicalTrials.gov processed this record on March 31, 2015
||Dr. Arkadi Yakirevitch, Arkadi Yakirevitch, MD, Sheba Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 23, 2007
||December 17, 2012
||Israel: Israeli Health Ministry Pharmaceutical Administration