Clinical Trial: Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Carbylan Therapeutics, Inc.
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Reduction of postoperative synechia (adhesion)formation [ Time Frame: Post-operative through 60 days ]
Current Secondary Outcome:
Original Secondary Outcome: Subjective assessment of sinonasal symptoms post-operatively. [ Time Frame: Post-operative through 60 days ]
Information By: Carbylan Therapeutics, Inc.
Dates:
Date Received: November 2, 2007
Date Started: May 2007
Date Completion:
Last Updated: April 22, 2009
Last Verified: March 2009
