Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions

Sinusitis Clinical Trial

Official title:

Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02413125
• Other study ID #: 17882
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2015
• Last updated: April 12, 2015
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: University of Virginia
• Contact: Stephen R Bakos, M.D./Ph.D.
• Email: sb3qm[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Rhinosinusitis is one of the most prevalent diseases in the United States with an estimated 31 million adults diagnosed with this condition. The annual health care burden has been estimated to exceed 5.8 billion dollars. Unfortunately, the underlying etiology of rhinosinusitis is not fully understood and may encompass multiple factors including: anatomic variations, impaired immune function, ciliary dysfunction, seasonal allergies, aspirin allergy, and bacterial biofilms. There are a wide variety of treatment options aimed at reducing the symptoms of rhinosinusitis with nasal saline irrigations (NSI) being one of the foundations for therapeutic intervention.

The benefits of NSI in rhinosinusitis in reducing nasal symptoms have been demonstrated in multiple reports. The mechanisms in which NSI exerts its beneficial effects are not fully understood, though multiple theories exist including: improvement in mucociliary function, decreased nasal mucosal edema, and removal of infectious debris and allergens. NSI are administered intranasally with the use of an irrigation bottle with a wide variety of brands commercially available for patients to select. In the Department of Otolaryngology-Head and Neck Surgery Clinic at the University of Virginia Health System, NeiMed bottles are provided to patients who are diagnosed with rhinosinusitis. In addition, the patients are given an informational sheet regarding the care and cleaning of these irrigation bottles. Unfortunately, irrigation bottles can become colonized with bacteria including: Staphylococcus aureus, Streptococcus pneumonia, Pseudomonas aeruginosa, and Candida species. The contamination of irrigation bottles can be a nidus for continued bacterial introduction into the nasal cavity and therefore decreasing the beneficial effects of NSI.

Recently, a novel commercially available irrigation solution, the ChitoRhino, 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. There is a paucity of literature examining the beneficial effect of chitosan in decreasing bacterial contamination in irrigation bottles. This project represents a pilot study investigating the antimicrobial effects of chitosan in irrigation bottles for patients with rhinosinusitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinusitis

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Otolaryngology-Head and Neck Surgery at the University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial contamination of nasal saline irrigation bottle following normal saline solution assessed by performing a bacterial culture	Patients will be provided an irrigation bottle and instructed to use normal saline for 1 month. Following this period, the saline irrigation bottle will be collected and a bacterial culture of the irrigation bottle will be performed to determine the bacterial contamination present following use.	1 month	No
Primary	Bacterial contamination of nasal saline irrigation bottle following ChitoRhino irrigation solution assessed by performing a bacterial culture	Patients will be provided an irrigation bottle and instructed to use the ChitoRhino irrigation solution for 1 month. Following this period, the saline irrigation bottle will be collected and a bacterial culture of the irrigation bottle will be performed to determine the bacterial contamination present following use.	1 month	No