Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554190
• Other study ID #: ACOT 1.0
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2007
• Last updated: April 22, 2009
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Carbylan Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ethmoid Sinusitis
• Rhinosinusitis

Intervention

Device:
• AdvaCoat sinus gel
A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
• Merogel Injectable
Bioresorbable hyaluronic acid product

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Carbylan Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale		Post-operative through 60 days	No
Primary	Number of Participants With Solicited and Recorded Adverse Events		Post-operative through 60 days	No