Normal Paranasal Sinuses Microflora Study

Paranasal Sinuses Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426569
• Other study ID #: SHEBA-07-4534-AY-CTIL
• Status: Completed
• Phase: N/A
• First received: January 23, 2007
• Last updated: May 22, 2015
• Start date: February 2007
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Flora
• Paranasal Sinuses

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of bacteria in normal paranasal sinuses		at time of orthgnatic surgery	No