Recruiting

Nasal Saline

Sponsor:

University of Virginia

Code:

NCT02413125

Conditions

Sinusitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ChitoRhino irrigation solution

Normal saline

Study Details

Brief 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

Study ID

NCT02413125

Start date

Feb, 2015

Status verified date

Apr, 2015

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ChitoRino irrigation solution

The study participants will be provided a NeilMed irrigation bottle and instructed to administer 1 packet of ChitoRhino irrigation solution (premixed from manufacturer containing sea salt, Chitosan, and sodium bicarbonate). An informational sheet regarding care and cleaning of the irrigation bottle will be provided during the initial visit. Participants will be instructed to complete up to three nasal saline irrigations daily for 1 month and keep a log to determine compliance. After 1 month of use, the irrigation bottle will be returned at a second study visit.

experimental: Normal saline solution

The study participants will be provided a NeilMed irrigation bottle and instructed to administer nasal saline (250mL of 0.9% sodium chloride) irrigation solution. An informational sheet regarding care and cleaning of the irrigation bottle will be provided during the initial visit. Participants will be instructed to complete up to three nasal saline irrigations daily for 1 month and keep a log to determine compliance. After 1 month of use, the irrigation bottle will be returned at a second study visit.

Interventions

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.

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.

Primary outcome measure

  • Bacterial contamination of nasal saline irrigation bottle following normal saline solution assessed by performing a bacterial culture [ Time Frame: 1 month ]
  • Bacterial contamination of nasal saline irrigation bottle following ChitoRhino irrigation solution assessed by performing a bacterial culture [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Stephen R Bakos, M.D./Ph.D.

sb3qm@virginia.edu

Locations

Department of Otolaryngology-Head and Neck Surgery at the University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Stephen R Bakos, M.D./Ph.D.

sb3qm@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Apr 14, 2015

Last verified

Apr, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2015-04-14.