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Silastic Spacer for Sinusitis (SYNECHIAE Trial)

N/A
Waitlist Available
Led By Amin R Javer, MD, FRCSC, FARS
Research Sponsored by St. Paul's Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Sinusitis
  • Sinus Infection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed for the duration of post op standard of care, an expected average of 90 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed for the duration of post op standard of care, an expected average of 90 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
Secondary study objectives
Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.
Other study objectives
Sinonasal Outcomes Test-22 (SNOT- 22) score.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Silastic SpacerExperimental Treatment1 Intervention
This study arm receives the experimental treatment, a Silastic spacer.
Group II: Merocel SpacerActive Control1 Intervention
Merocel spacers are actively being used as the standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Silastic Spacer
2014
N/A
~50

Find a Location

Who is running the clinical trial?

St. Paul's Hospital, CanadaLead Sponsor
46 Previous Clinical Trials
13,072 Total Patients Enrolled
14 Trials studying Sinusitis
1,057 Patients Enrolled for Sinusitis
Amin R Javer, MD, FRCSC, FARSPrincipal InvestigatorSt. Paul's Hospital, Canada
4 Previous Clinical Trials
210 Total Patients Enrolled
4 Trials studying Sinusitis
210 Patients Enrolled for Sinusitis
~4 spots leftby Nov 2025
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