Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions

Status unconfirmed · Not applicable

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT02413125

Run by

University of Virginia

People needed

20

Starts

2015-02-01

Expected to finish

2015-06-01

Last updated by the study team

2015-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• participants will be: 18 years old or older,
• diagnosed with rhinosinusitis based on history and physical examination performed for clinical care
• intervention to be prescribed would include nasal irrigation,
• able to understand and comply with the study protocol instructions, including the return the irrigation bottles

You may not qualify if…

• children less than 18 years old,
• unable to understand or perform the saline irrigations, or protocol instructions including the return the irrigations bottles after 1 month of use
• prisoners
• those with shellfish allergies

Where it is running

• Department of Otolaryngology-Head and Neck Surgery at the University of Virginia Health System — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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