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Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions

NCT02413125 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-14

No results posted yet for this study

Summary

Rhinosinusitis is one of the most prevalent diseases within the United States and leads to decreased quality of life for patients suffering from this condition. A foundation in treatment for rhinosinusitis is nasal saline irrigations, which are administered through an irrigation bottle. The irrigation bottles are prone to contamination by bacterial and fungal species despite proper maintenance.

A new commercially available irrigation solution has been created using chitosan, a natural polysaccharide with antibacterial and antifungal properties. This research project will examine the ability of chitosan to decrease or prevent contamination of irrigation bottles after 1 month use by adult patients with rhinosinusitis.

Participants in this project will use either saline or chitosan irrigation solution for 1 month and then switch to the other solution for 1 month. Following 1 month of use, the irrigation bottles will be cultured to determine if chitosan irrigation solution decreased the contamination of the irrigation bottles.

Conditions

  • Sinusitis

Interventions

DEVICE

ChitoRhino irrigation solution

ChitoRhino irrigation solution has been developed with chitosan, a natural polysaccharide demonstrated to have antibacterial and antifungal properties. This polysaccharide has beneficial properties in multiple clinic applications including wound healing and post-operative sinus surgery. Chitosan's antimicrobial function develops from its polycationic structure. Chitosan interacts with the negatively charge bacterial wall, leading to disruption and cell lysis.

DRUG

Normal saline

Most nasal irrigations use normal saline (0.9% sodium chloride), which approximates the physiological concentration of plasma in the blood. The saline solution is used to flush the nose of mucous and allergens.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Stephen R Bakos, M.D./Ph.D. · Department of Otolaryngology-Head and Neck Surgery University of Virginia Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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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 NCT02413125 on ClinicalTrials.gov