Chronic Rhinosinusitis, Nasal Polyps
Conditions
Brief summary
This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone acetonide, a steroid, is more comfortable postoperatively for participants and is as effective in decreasing scarring, swelling and crusting after surgery than an FDA approved steroid eluting implant. Anticipated sample size will be 30. Study is an intrapatient control design. Subjects will be randomly assigned to receive CMC foam with triamcinolone in one nare and the steroid-eluting implant in the other. Participants will fill out preoperative and follow-up visit surveys at 7, 14, 30 and 90 days. Subjects at each visit will also have pictures taken of the nasal cavities to be scored for later analysis. Paired t-tests will be performed for analysis. Our primary objective is to demonstrate that triamcinolone-impregnated carboxymethylcellulose foam is noninferior to steroid-eluting implants in improving postoperative ethmoid inflammation, middle turbinate position, preventing intranasal synechiae and reducing polypoid change with objective measurement scales Our secondary objects include assessing the quality-of-life and nasal obstruction symptoms before and after functional endoscopic sinus surgery with validated SNOT-22 and NOSE questionnaires and to assess the cost-effectiveness of triamcinolone-impregnated carboxymethylcellulose foam versus steroid-eluting implant in management of CRSwNP in the early postoperative period. The endpoints are the POSE scores, the SNOT-22 and NOSE scores at days 7, 14, 30 and 90.
Interventions
DRUGTriamcinolone-impregnated CMC foam
same information as included in the arm/group descriptions
DEVICEPropel Stent
same information as included in the arm/group descriptions
Sponsors
State University of New York - Downstate Medical Center
Marina Boruk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcomes assessor will be blinded to the side that the steroid eluting implant and the triamcinolone-impregnated foam in on.
Intervention model description
Study is an intrapatient control design, each subject will receive both interventions, one in each nostril
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Diagnosis of nasal polyposis and desiring surgery
Exclusion criteria
* A known history of intolerance to corticosteroids * An oral steroid-dependent condition * A history of immune deficiency * Pre-existing narrow angle glaucoma or cataracts * Subjects that did not complete the pre-op medical regimen described below * Pregnant and/or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Perioperative Sinus Endoscopy Score | 30 days | The Perioperative Sinus Endoscopy score sums the combined scores determined from middle turbinate position, middle meatal status, ethmoid cavity appearance, as well as secondary sinus blockage (frontal and sphenoid). Each category is scored from 0-2, with 0 being not present, 1 as partially present, and 2 being fully present. The highest total score is 16, with scores ranging from 18-20 when the frontal and sphenoid sinuses are also included. The higher the score, the worse the status of the nasal cavity. Comparison of the mean POSE scores for the two treatments at day 30 to determine there is noninferiority |
Countries
United States
Contacts
Primary ContactMarina Boruk, MD
Backup ContactMatthew D Adams, MD
Outcome results
None listed