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The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery

NCT02562924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-16

Study results available
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Summary

This study will assess the effectiveness of MEDIHONEY® sinus rinses (alone or in combination with intranasal corticosteroids) vs. intranasal corticosteroid sinus rinses on mucosal healing and polyp recurrence in the post-operative period following functional endoscopic sinus surgery.

Conditions

  • Chronic Sinusitis
  • Nasal Polyposis

Interventions

DEVICE

MEDIHONEY®

MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties

DRUG

Budesonide

Topical steroid

DRUG

Normal saline sinus rinse

8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle

DRUG

Prednisone

Post-operatively, 40 mg daily for 7 days

PROCEDURE

Endoscopic sinus surgery

Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage

DRUG

nasal saline spray

saline nasal mist every hour while awake

Sponsors & Collaborators

  • University of Vermont Medical Center

    lead OTHER

Principal Investigators

  • Gary P Landrigan, MD · University of Vermont Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02562924 on ClinicalTrials.gov