The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- University of Calgary
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sinonasal mucosal healing
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Saline
Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery
Intervention: Saline (Drug)
Dexamethasone
Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Sinonasal mucosal healing
Time Frame: 1 month
Secondary Outcomes
- Sinonasal quality of life (SNOT-22)(1 month)