Status:
COMPLETED
Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study
Lead Sponsor:
St. Paul's Hospital, Canada
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
Brief Summary
Povidone Iodine solution is a nasal antiseptic. Its application has been shown to be clinically safe, tolerable and effective against bacteria and fungi associated with chronic rhinosinusitis. This s...
Detailed Description
Background and scientific rationale Chronic rhinosinusitis (CRS) is an inflammatory condition of the paranasal sinuses affecting millions of patients, resulting in billions of dollars being spent annu...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 19 years or older
- Diagnosed with CRS with biofilm recalcitrant/recurrent after a trial of at least 3 months of a combination of well executed sinus surgery, regular irrigation with topical steroids or mucosal atomization device and surfactants24
- Continued symptoms colored nasal discharge, post nasal drip, nasal congestion, decreased sense of smell, mucosal edema or polyps despite the above stated intervention
- Exclusion Criteria
- Patients with sinonasal tumors.
- Patients with autoimmune diseases affecting the upper airway
- o eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc.
- Immuno-compromised patients, and patients with impairment in mucociliary function
- o (e.g., cystic fibrosis, Kartagener syndrome)
- Hypersensitivity to iodine
- History of thyroid disorders including thyroid cancer, hyperthyroidism and hypothyroidism
- Use of medications for thyroid disorders including thyroxine and carbimazole
- Pregnancy
- Patients unable to speak English.
Exclusion
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04097613
Start Date
July 28 2017
End Date
August 31 2019
Last Update
September 20 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6