Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ethmoid Sinusitis Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing

Group Type EXPERIMENTAL

AdvaCoat sinus gel

Intervention Type DEVICE

A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body

2

Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat

Group Type ACTIVE_COMPARATOR

Merogel Injectable

Intervention Type DEVICE

Bioresorbable hyaluronic acid product

Interventions

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AdvaCoat sinus gel

A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body

Intervention Type DEVICE

Merogel Injectable

Bioresorbable hyaluronic acid product

Intervention Type DEVICE

Other Intervention Names

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Merogel

Eligibility Criteria

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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