Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions
Avainsanat
Abstrakti
Kuvaus
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.
Päivämäärät
Viimeksi vahvistettu: | 03/31/2015 |
Ensimmäinen lähetys: | 02/17/2015 |
Arvioitu ilmoittautuminen lähetetty: | 04/07/2015 |
Ensimmäinen lähetetty: | 04/08/2015 |
Viimeisin päivitys lähetetty: | 04/11/2015 |
Viimeisin päivitys lähetetty: | 04/13/2015 |
Todellinen opintojen alkamispäivä: | 01/31/2015 |
Arvioitu ensisijainen valmistumispäivä: | 05/31/2015 |
Arvioitu tutkimuksen valmistumispäivä: | 05/31/2015 |
Ehto tai tauti
Interventio / hoito
Device: ChitoRino irrigation solution
Drug: Normal saline solution
Vaihe
Varren ryhmät
Varsi | Interventio / hoito |
---|---|
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. | Device: ChitoRino 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. |
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. | Drug: Normal saline solution 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. |
Kelpoisuusehdot
Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
Sukupuolet, jotka ovat kelpoisia tutkimukseen | All |
Hyväksyy terveelliset vapaaehtoiset | Joo |
Kriteeri | 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 |
Tulokset
Ensisijaiset tulosmittaukset
1. Bacterial contamination of nasal saline irrigation bottle following normal saline solution assessed by performing a bacterial culture [1 month]
2. Bacterial contamination of nasal saline irrigation bottle following ChitoRhino irrigation solution assessed by performing a bacterial culture [1 month]