Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 18, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedApril 14, 2015
April 1, 2015
4 months
February 18, 2015
April 12, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
ChitoRino irrigation solution
EXPERIMENTALThe 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.
Normal saline solution
EXPERIMENTALThe 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 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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Otolaryngology-Head and Neck Surgery at the University of Virginia Health System
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen R Bakos, M.D./Ph.D.
Department of Otolaryngology-Head and Neck Surgery University of Virginia Health System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Physician
Study Record Dates
First Submitted
February 18, 2015
First Posted
April 9, 2015
Study Start
February 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
April 14, 2015
Record last verified: 2015-04