Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Phase 4

Completed

• Conditions: Ethmoid Sinusitis; Rhinosinusitis
• Interventions: Device: AdvaCoat sinus gel; Device: Merogel Injectable

• Registration Number: NCT00554190
• Lead Sponsor: Carbylan Therapeutics, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-11-14
• Status Verified: 2009-03
• Results First Submitted QC: 2009-04-22
• Last Update Submitted: 2009-04-22
• Results First Posted: 2009-04-23
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Patients who:

1. Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography
2. Have bilateral ethmoid sinus disease
3. Are scheduled for bilateral anterior or total ethmoidectomy

Exclusion Criteria

1. Unilateral ethmoid sinus disease
2. Partial resection of middle turbinates, unilateral or bilateral

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AdvaCoat sinus gel	AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing
2	Merogel Injectable	Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat

Primary Outcome Measures

Name	Time	Method
Number of Participants With Solicited and Recorded Adverse Events	Post-operative through 60 days	All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized.
Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale	Post-operative through 60 days	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.

Trial Locations

Locations (4)

Alabama Nasal & Sinus Center; 🇺🇸 Birmingham, Alabama, United States

Northwestern University Medical Center, Department of Otolaryngology; 🇺🇸 Chicago, Illinois, United States

Cleveland Nasal Sinus & Sleep; 🇺🇸 Cleveland, Ohio, United States

University of California, San Francisco, Dept of Otolaryngology; 🇺🇸 San Francisco, California, United States