Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Carbylan Therapeutics

Status and phase: Completed; Phase 4

Conditions: Rhinosinusitis; Ethmoid Sinusitis

Treatments: Device: Merogel Injectable; Device: AdvaCoat sinus gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00554190

ACOT 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

1

Experimental group

Description:

AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing

Treatment:

Device: AdvaCoat sinus gel

2

Active Comparator group

Description:

Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat

Treatment:

Device: Merogel Injectable