Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

(SYNECHIAE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Amin R Javer, MD, FRCSC, FARS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: St. Paul's Hospital, Canada

No Placebo Group

Trial Summary

What is the purpose of this trial?

Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.

Research Team

Amin R Javer, MD, FRCSC, FARS

Principal Investigator

St. Paul's Hospital, Canada

Eligibility Criteria

Inclusion Criteria

Patients over the age of 19 years, currently receiving sinus-related care at the St Paul's Sinus Centre for chronic rhinosinusitis and who undergo primary bilateral complete endoscopic sinus surgery will be approached to participate in this clinical trial.

Treatment Details

Interventions

• Merocel Spacer (Spacer)
• Silastic Spacer (Spacer)

Participant Groups

Group I: Silastic Spacer Experimental Treatment 1 Intervention

This study arm receives the experimental treatment, a Silastic spacer.

Group II: Merocel Spacer Active Control 1 Intervention

Merocel spacers are actively being used as the standard of care.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

St. Paul's Hospital Sinus Centre Vancouver, Canada

Who Is Running the Clinical Trial?

St. Paul's Hospital, Canada

Lead Sponsor

Trials

48

Patients Recruited

13,200+