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

University of Calgary

Status and phase: Unknown; Phase 4

Conditions: Chronic Rhinosinusitis

Treatments: Drug: Saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01024075

22476

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery

Treatment:

Drug: Saline

Dexamethasone

Active Comparator group

Description:

Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery

Treatment:

Drug: Dexamethasone