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Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

NCT03607175 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • State University of New York - Downstate Medical Center

    collaborator OTHER

  • Marina Boruk

    lead OTHER

Principal Investigators

  • Marina Boruk, MD · SUNY Downstate Med Ctr

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2025-09-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03607175 on ClinicalTrials.gov