Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    30
  • sponsor
    Marina Boruk
Updated on 12 February 2022
edema
cavities
scarring
rhinosinusitis
obstruction
propel
nasal polyp
sinus surgery
polyposis
nasal packing
Accepts healthy volunteers

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.

Details
Condition Chronic Rhinosinusitis, Nasal Polyps
Treatment Triamcinolone-impregnated CMC foam, Propel Stent
Clinical Study IdentifierNCT03607175
SponsorMarina Boruk
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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