Nasospore Stent For Use in Enodscopic Sinus Surgery

Lahey Clinic

Overview

The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.

This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Chronic Sinusitis

Interventions

Merogel Nasal Stent and Nasopore StentDRUG

Merogel Nasal Stent and Nasopore Stent

Nasopore Stent and either Gentamycin or BacitracinDRUG

Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Evaluation by Otolaryngologist \& determined to need endoscopic sinus surgery * Only subjects with Bilateral disease Exclusion Criteria: * Pediatric subjects(under the age of 18)

Locations (1)

Lahey Clinic, Inc

Burlington, Massachusetts, United States

Outcomes

Primary Outcomes

This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution

Time frame: prospective

Data from ClinicalTrials.gov

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