NCT03607175

Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Marina Boruk · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Rhinosinusitis
• Nasal Polyps

Interventions

Type	Name	Description
DRUG	Triamcinolone-impregnated CMC foam	same information as included in the arm/group descriptions
DEVICE	Propel Stent	same information as included in the arm/group descriptions

Timeline

• Start date: 2023-07-24
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2018-07-31
• Last updated: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study