Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.

Detailed Description
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Chronic rhinosinusitis is a very common condition, affecting 35 million Americans each year. All paranasal sinuses need ventilation to prevent infection and inflammation. Sinus ventilation occurs through the ostia into the nose. When rhinosinusitis occurs, the mucous membranes of the sinuses become swollen, resulting in ostia closure. Functional endoscopic sinus surgery (FESS) is a minimally invasive surgical procedure that opens the sinus ostia. The most common unwanted side effect of the FESS procedure is the formation of adhesions (fibrous bands) in the area of surgery. These bands (adhesions) can prevent proper ventilation and drainage from the paranasal sinuses. Various hyaluronan based biomaterials are now available and in common use to provide a post-surgical nasal dressing which is absorbable, can prevent adhesion formation, and eliminate the pain and tissue abrasion caused by removal of non-absorbable nasal packing. AdvaCoat is a bioresorbable hyaluronan gel that conforms to mucosal surfaces and provides a post-surgical nasal dressing to prevent adhesion formation as tissues heal.

Official Title
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A Prospective, Multi-Center, Randomized, Controlled, Subject-Blinded Study to Evaluate the Safety and Effectiveness of AdvaCoat Sinus Gel Following Endoscopic Ethmoid Sinus Surgery

Conditions
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Ethmoid Sinusitis, Rhinosinusitis

Intervention / Treatment
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* Device: AdvaCoat sinus gel
* Device: Merogel Injectable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who: Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography Have bilateral ethmoid sinus disease Are scheduled for bilateral anterior or total ethmoidectomy Exclusion Criteria: Unilateral ethmoid sinus disease Partial resection of middle turbinates, unilateral or bilateral

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing | Device: AdvaCoat sinus gel<br>* A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body<br>|
| Active Comparator: 2<br>Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat | Device: Merogel Injectable<br>* Bioresorbable hyaluronic acid product<br>* Other names: Merogel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment. | Post-operative through 60 days | 
| Number of Participants With Solicited and Recorded Adverse Events | All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized. | Post-operative through 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinosinusitis, ethmoid