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Trial registered on ANZCTR


Registration number
ACTRN12616001558415
Ethics application status
Approved
Date submitted
7/11/2016
Date registered
11/11/2016
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Date results information initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of colloidal silver in chronic rhinosinusitis
Scientific title
The effect of colloidal silver sinonasal rinses in recalcitrant chronic rhinosinusitis
Secondary ID [1] 289757 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 299614 0
Condition category
Condition code
Infection 299579 299579 0 0
Other infectious diseases
Respiratory 300706 300706 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295452 0
Treatment: Drugs
Comparator / control treatment
Patients in the control group will receive 20 pre-prepared sinonasal flush
bottles containing an isotonic saline solution. They will be asked to utilise
the flushes twice daily for 10 days. They will also receive 20 encapsulated antibiotic tablets (either 1g amoxicillin/clavulanic acid or 500mg clarithromycin) and will be requested to take these orally twice a day 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.

If patients culture a positive swab at 10 days, they will immediately be crossed over to the treatment group, and 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.
Control group
Placebo

Outcomes
Primary outcome [1] 299087 0
Presence/absence of growth on culture from sinonasal swab.
Timepoint [1] 299087 0
Immediately pre-treatment (t = 0 days) & immediately post-treatment (t = 10 days). If the patient is crossed over to the other arm (i.e. still has active infection indicated by positive growth on sinonasal swab after 10 days of initial treatment), another swab will also be performed at t = 20 days.
Secondary outcome [1] 326110 0
Change in endoscopic sinus score (Modified Lund-Kennedy score).
Timepoint [1] 326110 0
Immediately pre-treatment (t = 0 days) & immediately post-treatment (t = 10 days). If the patient is crossed over to the other arm (i.e. still has active infection indicated by positive growth on sinonasal swab after 10 days of initial treatment), another endoscopic score will also be assessed at t = 20 days.
Secondary outcome [2] 329113 0
Change in subjective symptom questionnaires (Visual Analogue Scale & SNOT-22).
Timepoint [2] 329113 0
Immediately pre-treatment (t = 0 days) & immediately post-treatment (t = 10 days). If the patient is crossed over to the other arm (i.e. still has active infection indicated by positive growth on sinonasal swab after 10 days of initial treatment), another symptom questionnaire will also be assessed at t = 20 days.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant
Under age of 18
Cannot consent for themselves
Allergy to penicillin/clarithromycin/ciprofloxacin
Allergy to silver/nickel

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will involve the investigator contacting the person who is the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be employed. This will be undertaken using the software excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
ANOVA and student's T test, with significance set at p<0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6304 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 13839 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 294164 0
University
Name [1] 294164 0
University of Adelaide
Address [1] 294164 0
Department of Otorhinolaryngology
28 Woodville Rd
Woodville South 5011
South Australia
Country [1] 294164 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South 5011
South Australia
Country
Australia
Secondary sponsor category [1] 292997 0
University
Name [1] 292997 0
University of Adelaide
Address [1] 292997 0
Adelaide 5005
South Australia
Country [1] 292997 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295574 0
HUMAN RESEARCH ETHICS COMMITTEE (The Queen Elizabeth Hospital/Lyell McEwin Hospital/Mdobury Hospital)
Ethics committee address [1] 295574 0
The Queen Elizabeth Hospital
Ethics: DX465101
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 295574 0
Australia
Date submitted for ethics approval [1] 295574 0
28/07/2016
Approval date [1] 295574 0
31/10/2016
Ethics approval number [1] 295574 0
Q20151109

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67710 0
Prof Peter-John Wormald
Address 67710 0
The Queen Elizabeth hospital 28 Woodville Rd, Woodville, 5011 South
Australia
Country 67710 0
Australia
Phone 67710 0
+61 8 82227158
Fax 67710 0
Email 67710 0
peterj.wormald@adelaide.edu.au
Contact person for public queries
Name 67711 0
Prof Peter-John Wormald
Address 67711 0
The Queen Elizabeth hospital 28 Woodville Rd, Woodville, 5011 South
Australia
Country 67711 0
Australia
Phone 67711 0
+61 8 82227158
Fax 67711 0
Email 67711 0
peterj.wormald@adelaide.edu.au
Contact person for scientific queries
Name 67712 0
Dr Sarah Vreugde
Address 67712 0
The Queen Elizabeth hospital 28 Woodville Rd, Woodville, 5011 South
Australia
Country 67712 0
Australia
Phone 67712 0
+61 8 82227158
Fax 67712 0
Email 67712 0
sarah.vreugde@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5894 0
Download Article
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ORIGINAL RESEARCH ARTICLE
Front. Microbiol., 11 April 2018 | https://doi.org/10.3389/fmicb.2018.00720
Topical Colloidal Silver for the Treatment of Recalcitrant Chronic Rhinosinusitis
Mian L. Ooi1, Katharina Richter1,2, Catherine Bennett1, Luis Macias-Valle1,3, Sarah Vreugde1, Alkis J. Psaltis1 and Peter-John Wormald1*
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary