Ethmoid Sinusitis, Rhinosinusitis
Conditions
Keywords
rhinosinusitis, ethmoid
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 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.
Interventions
DEVICEAdvaCoat sinus gel
A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
DEVICEMerogel Injectable
Bioresorbable hyaluronic acid product
Sponsors
Carbylan Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | Post-operative through 60 days | 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. |
| Number of Participants With Solicited and Recorded Adverse Events | Post-operative through 60 days | All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized. |
Countries
United States
Participant flow
Recruitment details
First subject treatment: May 2007. Last subject treatment: December 2007.
Pre-assignment details
A total of 29 subjects were treated. Nineteen subjects were followed through 60 days post-treatment.
Participants by arm
| Arm | Count |
|---|---|
| AdvaCoat and Merogel Injectable AdvaCoat compared with Merogel Injectable | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Termination forms not completed | 10 |
Baseline characteristics
| Characteristic | AdvaCoat and Merogel Injectable |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age Continuous | 42 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 15 Participants |
Outcome results
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.
Time frame: Post-operative through 60 days
Population: There were 19 participants that completed the final follow-up visit at 60 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Merogel Injectable | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 0 (no visible synechia) | 14 Participants |
| Merogel Injectable | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 1 (one or several visible synechia) | 4 Participants |
| Merogel Injectable | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 2 (synechia w/ interference to sinus ventilation ) | 1 Participants |
| Merogel Injectable | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 3 (complete scarring) | 0 Participants |
| AdvaCoat Sinus Gel | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 3 (complete scarring) | 0 Participants |
| AdvaCoat Sinus Gel | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 0 (no visible synechia) | 13 Participants |
| AdvaCoat Sinus Gel | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 2 (synechia w/ interference to sinus ventilation ) | 1 Participants |
| AdvaCoat Sinus Gel | Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale | 1 (one or several visible synechia) | 5 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.
Time frame: Post-operative through 60 days
Population: There were 19 participants who completed the 60 day follow up visits for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Merogel Injectable | Number of Participants With Solicited and Recorded Adverse Events | Mucopurulent drainage | 1 Participants |
| Merogel Injectable | Number of Participants With Solicited and Recorded Adverse Events | Mucopurulent drainage with polypoid swelling | 2 Participants |
| AdvaCoat Sinus Gel | Number of Participants With Solicited and Recorded Adverse Events | Mucopurulent drainage | 2 Participants |
| AdvaCoat Sinus Gel | Number of Participants With Solicited and Recorded Adverse Events | Mucopurulent drainage with polypoid swelling | 2 Participants |