drugset / Trial / NCT02403479

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

NCT02403479 ↗

RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2015-12-10
Primary completion
2016-03-06
Completion
2017-04-08

Outcome

Missed primary endpoint

paper Mean 6-week change in SNOT-22 scores were -2.8 and 1.0 for saline and CS, respectively (p = 0.373). PMID 29178954 ↗

paper Similarly, mean 6-week change in LK scores were -1.4 and -1.1 for saline and CS, respectively (p = 0.794). PMID 29178954 ↗

paper Commercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP. PMID 29178954 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Silver Colloid Unknown 6.7 ug Intranasal