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Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554190
First Posted: November 6, 2007
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Carbylan Therapeutics, Inc.
  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. 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.

Condition Intervention Phase
Ethmoid Sinusitis Rhinosinusitis Device: AdvaCoat sinus gel Device: Merogel Injectable Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Therapeutics, Inc.:

Primary Outcome Measures:
  • Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale [ Time Frame: Post-operative through 60 days ]
  • Number of Participants With Solicited and Recorded Adverse Events [ Time Frame: Post-operative through 60 days ]

Enrollment: 29
Study Start Date: May 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing
Device: AdvaCoat sinus gel
A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
Active Comparator: 2
Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat
Device: Merogel Injectable
Bioresorbable hyaluronic acid product
Other Name: Merogel

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Therapeutics, Inc.
Investigators
Principal Investigator: Andrew N. Goldberg, MD University of California, San Francisco, Medical Center
  More Information

Responsible Party: Marcee Maroney, V.P. Marketing and Clinical Affairs, Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier: NCT00554190     History of Changes
Other Study ID Numbers: ACOT 1.0
First Submitted: November 2, 2007
First Posted: November 6, 2007
Results First Submitted: November 14, 2008
Results First Posted: April 23, 2009
Last Update Posted: July 29, 2009
Last Verified: March 2009

Keywords provided by Carbylan Therapeutics, Inc.:
rhinosinusitis, ethmoid

Additional relevant MeSH terms:
Sinusitis
Ethmoid Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases