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Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

This study has been completed.
Sponsor:
Information provided by:
Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier:
NCT00554190
First received: November 2, 2007
Last updated: April 22, 2009
Last verified: March 2009
History of Changes
  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 Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale [ Time Frame: Post-operative through 60 days ] [ Designated as safety issue: No ]
  • Number of Participants With Solicited and Recorded Adverse Events [ Time Frame: Post-operative through 60 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Study First Received: November 2, 2007
Results First Received: November 14, 2008
Last Updated: April 22, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013