Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Marina Boruk
• Collaborator: State University of New York - Downstate Medical Center
• Treatments: Carboxymethylcellulose Sodium; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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