NCT02562924

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

An Open-label, Prospective, Randomized, Pilot Clinical Study to Study the Efficacy of MEDIHONEY® Rinses Compared to Intranasal Corticosteroid Rinses in Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Vermont Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In patients with refractory CRSwNP, functional endoscopic sinus surgery (FESS), is intended to restore physiologic sinus ventilation and drainage, which can facilitate the gradual resolution of mucosal disease. However, because FESS does not directly treat the underlying inflammatory disorder, a successful sinus surgery must be followed by medical maintenance therapy to control inflammatory processes. The current mainstay of treatment of CRSwNP includes antibiotics and topical and systemic steroids. There is evidence that administration of systemic steroids in the postoperative period for patients who have polyps may have a significant impact on their postoperative course. However, the chance of significant side effects increases with the dose and duration of treatment and therefore the minimum dose necessary to control the disease should be given. Antibiotics also have their limited but documented side effects and can induce resistance. A semi-natural product like manuka honey (brand name MEDIHONEY®), with antibacterial and anti-inflammatory properties, might prove as a useful alternative since it has no major adverse events documented in the literature, does not induce resistance and is effective against resistant pathogens common in this patient population. This study is a prospective, randomized, pilot clinical trial that will determine if the use of MEDIHONEY® sinus rinses (alone or in combination with intranasal steroids) in the postoperative period enhances recovery and prevents polyp recurrence in patients after functional endoscopic sinus surgery (FESS), compared with the standard regimen of topical corticosteroid sinus rinses. The study will collect and compare subjective and objective efficacy assessments of both types of rinses.

Conditions

• Chronic Sinusitis
• Nasal Polyposis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-09-29
• Last updated: 2019-10-16
• Results posted: 2019-10-16

Locations

1 site across 1 country: United States