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

Chronic Rhinosinusitis Clinical Trial

Official title:

The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01024075
• Other study ID #: 22476
• Status: Recruiting
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: December 1, 2009
• Start date: November 2009
• Est. completion date: May 2011

Study information

• Verified date: December 2009
• Source: University of Calgary
• Contact: Luke Rudmik, MD
• Phone: 403-212-8223
• Email: Lukerudmik[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Intervention

Drug:
• Dexamethasone
4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam
• Saline
8cc of Saline mixed with Sinufoam

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinonasal mucosal healing		1 month	No
Secondary	Sinonasal quality of life (SNOT-22)		1 month	No