Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Marina Boruk
Collaborator:
State University of New York - Downstate Medical Center