Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

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. Identifier: NCT00554190
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : April 23, 2009
Last Update Posted : April 23, 2009
Information provided by:
Carbylan Therapeutics, Inc.

November 2, 2007
November 6, 2007
November 14, 2008
April 23, 2009
April 23, 2009
May 2007
December 2007   (Final data collection date for primary outcome measure)
  • 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 ]
Reduction of postoperative synechia (adhesion)formation [ Time Frame: Post-operative through 60 days ]
Complete list of historical versions of study NCT00554190 on Archive Site
Not Provided
Subjective assessment of sinonasal symptoms post-operatively. [ Time Frame: Post-operative through 60 days ]
Not Provided
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Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
A Prospective, Multi-Center, Randomized, Controlled, Subject-Blinded Study to Evaluate the Safety and Effectiveness of AdvaCoat Sinus Gel Following Endoscopic Ethmoid Sinus Surgery
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Ethmoid Sinusitis
  • Rhinosinusitis
  • Device: AdvaCoat sinus gel
    A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
  • Device: Merogel Injectable
    Bioresorbable hyaluronic acid product
    Other Name: Merogel
  • Experimental: 1
    AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing
    Intervention: Device: AdvaCoat sinus gel
  • Active Comparator: 2
    Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat
    Intervention: Device: Merogel Injectable
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
ACOT 1.0
Not Provided
Not Provided
Marcee Maroney, V.P. Marketing and Clinical Affairs, Carbylan BioSurgery, Inc.
Carbylan Therapeutics, Inc.
Not Provided
Principal Investigator: Andrew N. Goldberg, MD University of California, San Francisco, Medical Center
Carbylan Therapeutics, Inc.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP