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

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.

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

Conditions
-----------------
Chronic Rhinosinusitis

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br>Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery | Drug: Saline<br>* 8cc of Saline mixed with Sinufoam<br>|
| Active Comparator: Dexamethasone<br>Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery | Drug: Dexamethasone<br>* 4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinonasal mucosal healing |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinonasal quality of life (SNOT-22) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Rhinosinusitis, Endoscopic sinus surgery, Sinufoam, Dexamethasone, For patients with Chronic Rhinosinusitis without nasal polyps, Focus: Define the postoperative sinonasal mucosal healing status of 2 Sinufoam mixtures