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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AdvaCoat compared to Merogel Injectable Bioresorbable Nasal Dressing |
|
| 2 | Active Comparator | Merogel Injectable Bioresorbable Nasal Dressing compared to AdvaCoat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdvaCoat sinus gel | Device | A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment. | Post-operative through 60 days |
| Number of Participants With Solicited and Recorded Adverse Events | All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized. | Post-operative through 60 days |
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Inclusion Criteria:
Patients who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew N. Goldberg, MD | University of California, San Francisco, Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Nasal & Sinus Center | Birmingham | Alabama | 35242 | United States | ||
| University of California, San Francisco, Dept of Otolaryngology |
A total of 29 subjects were treated. Nineteen subjects were followed through 60 days post-treatment.
First subject treatment: May 2007. Last subject treatment: December 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | AdvaCoat and Merogel | AdvaCoat compared to Merogel Injectable. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AdvaCoat and Merogel Injectable | AdvaCoat compared with Merogel Injectable |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment. | There were 19 participants that completed the final follow-up visit at 60 days. | Posted | Number | Participants | Post-operative through 60 days |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcee Maroney, VP Clinical Affairs | Carbylan BioSurgery Inc. | 650 855 6774 | mmaroney@carbylan.com |
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| ID | Term |
|---|---|
| D015521 | Ethmoid Sinusitis |
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
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| Merogel Injectable | Device | Bioresorbable hyaluronic acid product |
|
|
| San Francisco |
| California |
| 94143 |
| United States |
| Northwestern University Medical Center, Department of Otolaryngology | Chicago | Illinois | 60611 | United States |
| Cleveland Nasal Sinus & Sleep | Cleveland | Ohio | 44125 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Solicited and Recorded Adverse Events | All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized. | There were 19 participants who completed the 60 day follow up visits for analysis. | Posted | Number | Participants | Post-operative through 60 days |
|
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| D009668 |
| Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012220 | Rhinitis |