Clinical trial NCT00554190: Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ethmoid Sinusitis
Rhinosinusitis
Keywords: rhinosinusitis, ethmoid
Lead sponsor: Carbylan Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale
timeFrame: Post-operative through 60 days
measure: Number of Participants With Solicited and Recorded Adverse Events
timeFrame: Post-operative through 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Nasal & Sinus Center
state: Alabama
city: San Francisco
country: United States
facility: University of California, San Francisco, Dept of Otolaryngology
state: California
city: Chicago
country: United States
facility: Northwestern University Medical Center, Department of Otolaryngology
state: Illinois
city: Cleveland
country: United States
facility: Cleveland Nasal Sinus & Sleep
state: Ohio
Study officials:
affiliation: University of California, San Francisco, Medical Center
name: Andrew N. Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: