Phase 2 N=22 Randomized Single-blind Treatment

The Effectiveness of Topical Silver Colloid in Treating Patients With Recalcitrant Chronic Rhinosinusitis

Rhinosinusitis

Bottom Line

View on ClinicalTrials.gov: NCT02403479 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks. — 59.3; 52.9; 45.4; 51.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Silver Colloid (Drug); Saline (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.	59.3; 52.9; 45.4; 51.8; 49.3; 56.5	—
PRIMARY Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks	7.8; 6.8; 5.9; 5.7; 4.8; 4.7	—

Summary

Chronic rhinosinusitis without polyposis (CRSsP) is a very common condition that occurs when the lining of the sinuses becomes persistently irritated. Standard management options include topical steroids, antibiotics and surgery, but treatment-resistant CRSsP is frequently encountered. Bacterial biofilms are routinely detected within the nasal mucosa of CRSsP patients and are now thought to play an important role in the protracted nature of the disease. Colloidal silver is a widely used naturopathic agent that has recently been shown to eliminate bacteria, and in particular in vitro sinusitis biofilms, in laboratory studies. Although silver is currently used in a variety of chronic wound therapies, it has not yet been formally studied in people with CRSsP. It is our intention with this project to determine whether colloidal silver is a useful treatment strategy for patients with refractory CRS.

Eligibility Criteria

Inclusion Criteria

A history of twelve or more weeks with at least 2 of the following:
Nasal congestion
Mucus discharge from the nose or mucus that drips down the back of the throat
Facial pain or pressure
A decrease sense of smell
A history of at least 2 of the following
One or more failed functional endoscopic sinus surgeries for CRS
Failed oral, culture-directed antibiotic therapy for CRS
Failed oral or topical steroid therapy for CRS
Failed baby shampoo nasal irrigation therapy for CRS
Failed topical mupirocin therapy for CRS
Failed Manuka honey irrigations for CRS
Failed budesonide irrigations for CRS

Exclusion Criteria

Patients with nasal polyposis
Patients with existing autoimmune disorders
Patients with an allergy to silver
Patients with diabetes
Patients that have previously used colloidal silver as a naturopathic remedy
Patients that are pregnant, attempting/planning to become pregnant or breastfeeding
Patients below the age of 18 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02403479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.