Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study

• Status: Completed
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

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 study will evaluate the effectiveness of Povidone Iodine in this hard-to-treat patient group. Furthermore, the study will also further evaluate any side effects that may occur with the use of Povidone Iodine.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul's Hospital, Canada
• Treatments: Budesonide; Cadexomer iodine; Iodine; Povidone; Povidone-Iodine

Criteria

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.