Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis



Status:Recruiting
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 80
Updated:8/8/2018
Start Date:July 18, 2018
End Date:June 30, 2019
Contact:Boruk, MD
Email:marina.boruk@downstate.edu
Phone:646-481-1311

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Randomized Clinical Control Trial Comparing the Effects of a Steroid Eluting Implant Versus Triamcinolone-impregnated Carboxymethylcellulose Foam on the Postoperative Clinic Experience in Patients That Underwent Functional Endoscopic Surgery for Nasal Polyposis

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. Paried 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.


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
We found this trial at
1
site
450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
Phone: 646-481-1311
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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