Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes

Phase 4

• Conditions: Chronic Rhinosinusitis
• Interventions: Drug: Saline; Drug: Dexamethasone

• Registration Number: NCT01024075
• Lead Sponsor: University of Calgary

Brief Summary

Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of endoscopic sinus surgery, will improve sinonasal mucosal healing.

Detailed Description

Sinufoam is an FDA approved mixture, which is placed in the ethmoid cavity at the completion of an endoscopic sinus surgery procedure. Sinufoam prevents scarring and promotes healing of the sinonasal mucosa. Sinufoam is commonly mixed with saline, which enables it to be liquefied and gently placed into the ethmoid cavity. Recent practice of adding Dexamethasone to the sinufoam mixture has been hypothesized to promote healing by reducing chronic inflammation associated with CRS. Using topical dexamethasone mixed into the Sinufoam solution may improve patient care by preventing the systemic effects associated with post-operative systemic steroid use.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Status Verified: 2009-12
• Study First Submitted QC: 2009-12-01
• Last Update Submitted: 2009-12-01
• Study First Posted: 2009-12-02
• Last Update Posted: 2009-12-02
• Primary Completion: 2010-11
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age >18 years old
• Chronic Rhinosinusitis without nasal polyps --- defined according to the AAO guidelines
• Elective "Bilateral" sinus surgery requiring at a minimum of an Uncinectomy, Maxillary Antrostomy, and Anterior Ethmoidectomy.

Exclusion Criteria

• Uncorrectable coagulopathy
• Emergency procedure
• Unavailable for standard post operative follow-up
• Sinonasal neoplasm resections
• Excessive intra-operative bleeding requiring nasal packing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery
Dexamethasone	Dexamethasone	Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery

Primary Outcome Measures

Name	Time	Method
Sinonasal mucosal healing	1 month

Secondary Outcome Measures

Name	Time	Method
Sinonasal quality of life (SNOT-22)	1 month

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada