None listed
Conditions
Brief summary
Chronic sinusitis is a debilitating and costly disease. Consistent inflammation and infection of the sinuses causes headaches, facial pain, blockage of the nose and discharge from the nose. The cause of this condition is not fully understood, and it is difficult to treat with surgery being the recommended treatment for some patients. But even after surgery, many patient’s symptoms return, and they may need repeat surgeries in the future. We currently recommend sinus rinses after surgery as a way of keeping sinuses clean and clear and to assist with healing and reducing inflammation and infection. We have previously found that proper care post-operatively can reduce the chances of requiring further surgeries and part of our research has been assessing the different rinses. Our laboratory studies have shown that colloidal silver reduces infection load significantly. In the laboratory, we have improved this product’s manufacturing process by using extracts from gum tree fresh leaves which are abundant in Australia. The safety of colloidal silver was tested in the lab and according to the results it is safe to the sinuses. This clinical trial is aimed at assessing 1. The safety of colloidal silver administration by sino-nasal rinse by documenting any adverse effects and 2. The effect of sinonasal rinse of colloidal silver combined with topical antibiotics on infection load in chronic sinusitis, compared to standard-of-care oral antibiotic tablets. This will be assessed by endoscopic assessment of the sino-nasal tract by a doctor, measuring bacterial load in the laboratory and completion of symptom questionnaires by participants.
Interventions
Patients with symptomatic chronic rhinosinusitis who have had previous sinus surgery and have evidence of chronic rhinosinusitis on endoscopic examination will be recruited into this trial.
Patients will be blindly, randomly selected into one of three treatment arms (each n=11). Treatments will be dispensed and explained to the participants after informed consent has been gained at the outpatient clinic at The Queen Elizabeth Hospital (TQEH) or the private rooms of the Chief investigator. These
Patients with symptomatic chronic rhinosinusitis who have had previous sinus surgery and have evidence of chronic rhinosinusitis on endoscopic examination will be recruited into this trial. Patients will be blindly, randomly selected into one of three treatment arms (each n=11). Treatments will be dispensed and explained to the participants after informed consent has been gained at the outpatient clinic at The Queen Elizabeth Hospital (TQEH) or the private rooms of the Chief investigator. These tasks will be performed by the laboratory research coordinator. Arm 2: One arm (termed Treatment arm 2 in the study protocol) will receive both green synthesised colloidal silver produced at the Basil Hetzel Institute under sterile conditions (10ml stock of 44ppm in 200ml 5% dextrose nasal wash) delivered via sinonasal rinse and culture specific topical antibiotic (mupirocin 10 % nasal irrigation gel is delivered at a final concentration of 0.05% and tobramycin 125 mg/mL nasal irrigation solution at a final concentration of 0.625mg/ml in 200 mL saline nasal wash) for 28 days and placebo oral antibiotics (Microcrystalline cellulose capsules) 1 twice daily for 10 days. Arm 3: Another group (Treatment arm 3) will receive culture specific topical antibiotics (mupirocin and tobramycin as above) with placebo colloidal silver (5% dextrose with colouring agents 102, 133 and 124 in 200ml sinonasal wash) via sinonasal rinse for 28 days and placebo oral antibiotics (Microcrystalline cellulose capsules) 1 twice daily for 10 days. Arm 4: The final group (Treatment arm 4) will receive colloidal silver (as above) with placebo topical antibiotics (Hypromellose gel) twice daily for 28 days delivered via sinonasal rinse, and placebo oral antibiotics (Microcrystalline cellulose capsules) 1 twice daily for 10 days.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must have had at least two of the following symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure or lack of sense of smell) that has been previously persistent for greater than 3 months. Participants must have had endoscopic sinus surgery (ESS) and be able to start the trial anytime from two weeks post-operative. Participants must show evidence of chronic sinusitis by direct endoscopic examination. Participants must show evidence of infectious exacerbation by direct endoscopic examination and have a positive culture diagnosis with pathogens that show sensitivity to mupirocin and/or tobramycin and/or oral antibiotic. Participants must have the ability to administer daily sinus rinses for the duration of the treatment period. Participants must be aged 18 years or over. Participants must be able to give written informed consent. Participants must have the ability and willingness to attend several visits to the outpatients. Participants must have the willingness and ability to comply with the requirements of the protocol as determined by the Investigator.
Exclusion criteria
Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study. Pregnant and breastfeeding women will also be excluded. Participants who are actively taking oral steroids or antibiotics will be excluded from the study.
Outcome results
None listed