None listed
Conditions
Brief summary
The purpose of this study is to further explore the effect of colloidal silver sinonasal rinses in recalcitrant chronic rhinosinusitis. Colloidal silver has already shown to be effective as an anti-biofilm agent in Staphylococcus aureus chronic rhinosinusitis (CRS) in a sheep model (Rajiv et al, 2015). We aim to further evaluate the effects of colloidal silver in patients affected by recalcitrant CRS. The specific aim of this study is to investigate the effect of colloidal silver on persistent infection in patients who have already undergone surgical management for chronic rhinosinusitis (CRS).
Interventions
Patients in the treatment group will receive 20 pre-prepared sinonasal flush bottles containing 240 mL of colloidal silver solution at a concentration of 30 ppm (equivalent to approximately 0.03 g/L or 0.278 nM) to use twice daily for 10 days. They will also receive 20 encapsulated dextrose tablets and will be asked to take these orally twice daily for 10 days. Patients will be required to bring back the empty sinonasal rinse bottles to demonstrate they are compliant with the medication regimen.
Patients in the treatment group will receive 20 pre-prepared sinonasal flush bottles containing 240 mL of colloidal silver solution at a concentration of 30 ppm (equivalent to approximately 0.03 g/L or 0.278 nM) to use twice daily for 10 days. They will also receive 20 encapsulated dextrose tablets and will be asked to take these orally twice daily for 10 days. Patients will be required to bring back the empty sinonasal rinse bottles to demonstrate they are compliant with the medication regimen. If patients culture a positive swab at 10 days, they will be immediately crossed over to the control group, and receive 20 pre-prepared sinonasal flush bottles containing an isotonic saline solution, to be used for a further 10 days. They will also receive 20 encapsulated antibiotic tablets (either 1g amoxicillin/clavulanic acid or 500mg clarithromycin) to take orally twice daily for 10 days. Antibiotic use will be pre-prescribed by the treating surgeon before being sent to the pharmacy (who will be responsible for the blinding), and will be based on sinonasal swab results and will be an antibiotic that is sensitive to the organism cultured.
Sponsors
The Queen Elizabeth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of chronic rhinosinusitis. Undergone previous endoscopic sinus surgery for chronic rhinosinusitis at least 3 months ago or later. Active bacterial infection proved by positive sinonasal swab.
Exclusion criteria
Pregnant Under age of 18 Cannot consent for themselves Allergy to penicillin/clarithromycin/ciprofloxacin Allergy to silver/nickel
Outcome results
None listed