Nasospore Stent For Use in Enodscopic Sinus Surgery

Nasospore Stent For The Use in Endoscopic Sinus Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Drug: Merogel Nasal Stent and Nasopore Stent; Drug: Nasopore Stent and either Gentamycin or Bacitracin

Detailed Description

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Merogel stent vs. Nasopore Stent; This study has two arms consiting of 50 subjects each (100 total) Arm 1 will recieve the standard stent (merogel)in their right sinus and a nasopore stent in their left sinus.	Drug: Merogel Nasal Stent and Nasopore Stent; Merogel Nasal Stent and Nasopore Stent; Other Names: Merogel Stent; Nasopore Stent; Bacatracin soaked stent; Gentamicin soaked stent
Experimental: bacitracin vs. gentamicin treated stent; The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus.	Drug: Merogel Nasal Stent and Nasopore Stent; Merogel Nasal Stent and Nasopore Stent; Other Names: Merogel Stent; Nasopore Stent; Bacatracin soaked stent; Gentamicin soaked stent; Drug: Nasopore Stent and either Gentamycin or Bacitracin; Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS); Other Names: Merogel Stent; Nasopore Stent; Bacatracin soaked stent; Gentamicin soaked stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution	prospective

Collaborators and Investigators

• Sponsor: Lahey Clinic
• Investigators: Principal Investigator: Peter J. Catalano, MD, Lahey Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 5, 2008

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 16, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins; Bacitracin
• Other Study ID Numbers: LCID 2006-026