NCT00426569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

8.2 years

First QC Date

January 23, 2007

Last Update Submit

May 22, 2015

Conditions

Paranasal SinusesFlora

Outcome Measures

Primary Outcomes (1)

  • presence of bacteria in normal paranasal sinuses

    at time of orthgnatic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults undergoing orthognatic procedure

You may qualify if:

  • Necessity of maxillary sinus opening during orthognathic surgery
  • Negative history of chronic rhinitis or chronic sinusitis
  • Informed concent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Study Officials

  • Arkadi Yakirevitch, M.D.

    Department of Otorhinolaryngology-Head and Neck Surgery, Sheba Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Arkadi Yakirevitch, MD

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

February 1, 2007

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

IL(1)