Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery (SYNECHIAE)

St. Paul's Hospital, Canada

Status: Completed

Conditions: Sinusitis

Treatments: Device: Merocel Spacer; Device: Silastic Spacer

Study type: Interventional

Funder types: Other

Identifiers

NCT02077322

Synechiae-2014

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Patients with sino-nasal tumors
• Patients solely undergoing nasal septal reconstruction
• Patients with previous history of endoscopic sinus surgery
• Cystic fibrosis or syndromic patients
• Patients with autoimmune diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

48 participants in 2 patient groups

Silastic Spacer

Experimental group

Description:

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

Treatment:

Device: Silastic Spacer

Merocel Spacer

Active Comparator group

Description:

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

Treatment:

Device: Merocel Spacer