AdvaCoat™ Sinus Gel Study - Full Text View

Sponsored by:	Carbylan BioSurgery, Inc.
Information provided by:	Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier:	NCT00554190

Purpose

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.

Condition	Intervention	Phase
Ethmoid Sinusitis Rhinosinusitis	Device: AdvaCoat sinus gel	Phase IV

MedlinePlus related topics: Adhesions Endoscopy Sinusitis

Drug Information available for: Hyaluronate Sodium Hyaluronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Carbylan BioSurgery, Inc.:

Primary Outcome Measures:

Reduction of postoperative synechia (adhesion)formation [ Time Frame: Post-operative through 60 days ]

Secondary Outcome Measures:

Subjective assessment of sinonasal symptoms post-operatively. [ Time Frame: Post-operative through 60 days ]

Enrollment:	29
Study Start Date:	May 2007
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator AdvaCoat compared to another similar marketed sinonasal dressing.	Device: AdvaCoat sinus gel A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body.

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

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554190

Locations

United States, Alabama
Alabama Nasal & Sinus Center
Birmingham, Alabama, United States, 35242
United States, California
University of California, San Francisco, Dept of Otolaryngology
San Francisco, California, United States, 94143
United States, Illinois
Northwestern University Medical Center, Department of Otolaryngology
Chicago, Illinois, United States, 60611
United States, Ohio
Cleveland Nasal Sinus & Sleep
Cleveland, Ohio, United States, 44125

Sponsors and Collaborators

Carbylan BioSurgery, Inc.

Investigators

Principal Investigator:

Andrew N. Goldberg, MD

University of California, San Francisco, Medical Center

More Information

Responsible Party:	Carbylan BioSurgery, Inc. ( Marcee Maroney, V.P. Marketing and Clinical Affairs )
Study ID Numbers:	ACOT 1.0
Study First Received:	November 2, 2007
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00554190
Health Authority:	United States: Institutional Review Board

Keywords provided by Carbylan BioSurgery, Inc.:

rhinosinusitis,ethmoid

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Hyaluronic Acid
Ethmoid Sinusitis
Sinusitis

Additional relevant MeSH terms:

Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 15, 2009