Sinusitis Clinical Trial
Official title:
Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions
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.
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.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03584178 -
The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis
|
N/A | |
| Completed |
NCT06016335 -
MRI-based Synthetic CT Images of the Head and Neck
|
N/A | |
| Active, not recruiting |
NCT02278484 -
Sinus Balloon Dilation in Pediatric Patients
|
N/A | |
| Withdrawn |
NCT02071667 -
Association of Periostin Levels and Chronic Sinusitis
|
N/A | |
| Completed |
NCT01420471 -
Medicated Punctured-Glove-Finger Spacer Study
|
Phase 4 | |
| Completed |
NCT01118312 -
Study of Asthma and Nasal Steroids
|
Phase 4 | |
| Completed |
NCT00645762 -
Balloon REmodeling Antrostomy THErapy Study
|
Phase 2 | |
| Completed |
NCT01685229 -
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
|
||
| Active, not recruiting |
NCT03943121 -
The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
|
N/A | |
| Withdrawn |
NCT02900794 -
Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery
|
N/A | |
| Terminated |
NCT02630472 -
Topical Irrigation Therapy for CRS
|
Phase 1/Phase 2 | |
| Completed |
NCT01442740 -
15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients
|
N/A | |
| Completed |
NCT01001039 -
Validation of the Facial and Cephalic Pain Inventory
|
N/A | |
| Completed |
NCT01033799 -
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
|
N/A | |
| Completed |
NCT00242437 -
Hemostatic Matrix in Endoscopic Sinus Surgery
|
Phase 4 | |
| Completed |
NCT00335309 -
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
|
N/A | |
| Completed |
NCT00236522 -
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.
|
Phase 3 | |
| Completed |
NCT01717274 -
Hot Saline Irrigation Study
|
N/A | |
| Completed |
NCT01166945 -
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
|
N/A | |
| Completed |
NCT00747747 -
Sinuclean's Treatment Of Sinusitis' Symptoms
|
Phase 4 |