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Trial registered on ANZCTR


Registration number
ACTRN12621001507875
Ethics application status
Approved
Date submitted
2/08/2021
Date registered
4/11/2021
Date last updated
4/11/2021
Date data sharing statement initially provided
4/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Chitodex with steroid on patients having sinus surgery for chronic rhinosinusitis
Scientific title
A single-blinded randomised trial evaluating the efficacy of chitosan-dextran (Chitodex) gel with topical steroid versus PureRegen gel on post-operative outcomes in the treatment of Chronic Rhinosinusitis (CRS)
Secondary ID [1] 304256 0
None
Universal Trial Number (UTN)
U1111-1268-2032
Trial acronym
Linked study record
This study is a follow-up study to ACTRN12617000072314

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 321974 0
Condition category
Condition code
Respiratory 319699 319699 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be receiving all 3 of the following treatments:

Chitodex gel
- Generic name: Chitosan-dextran (device)
- Dose administered: 10mLs
- Duration of administration: Single dose at end of endoscopic sinus surgery
- Mode of administration: Topical administration onto newly widened sinus ostiums and sites of incised mucosa by surgeon
- Monitoring: Empty packaging serial numbers will be documented

Triamcinolone
- Generic name: Triamcinolone
- Dose administered: 1mLs (40mg/mL formulation)
- Duration of administration: Single dose at end of endoscopic sinus surgery
- Mode of administration: Topical administration (incorporated into Chitodex gel prior to administration when re-constituted by attending nurse) by surgeon
- Monitoring: Empty packaging serial numbers will be documented

Pulmicort nasal flushes
- Generic name: Budesonide
- Dose administered: 2mLs (1mg/2mLs formulation)
- Duration of administration: 10 weeks, commencing from 2 week post-surgery
- Mode of administration: 2mLs added to sinus rinses, once daily in self-administered rinses by patient
- Monitoring: Patient self-conducted daily surveys
Intervention code [1] 320595 0
Treatment: Drugs
Comparator / control treatment
The control group will be receiving all 2 of the following treatments:

PureRegen gel
- Generic name: Self-crosslinked hyaluronic acid hydrogel
- Dose administered: 10mLs
- Duration of administration: Single dose at end of endoscopic sinus surgery
- Mode of administration: Topical administration onto newly widened sinus ostiums and sites of incised mucosa
- Monitoring: Empty packaging serial numbers will be documented

Pulmicort nasal flushes
- Generic name: Budesonide
- Dose administered: 2mLs (1mg/2mLs formulation)
- Duration of administration: 10 weeks, commencing from 2 week post-surgery
- Mode of administration: 2mLs added to sinus rinses, once daily
- Monitoring: Patient self-conducted daily surveys
Control group
Active

Outcomes
Primary outcome [1] 328470 0
Frontal sinus ostium measurement assessed by direct visualisation using nasal endoscopy
Timepoint [1] 328470 0
Intra-operative (day 0), 2 weeks, 6 weeks, 12 weeks (primary timepoint) post-operative
Primary outcome [2] 328932 0
Maxillary sinus ostium measurement assessed by direct visualisation using nasal endoscopy
Timepoint [2] 328932 0
Intra-operative (day 0), 2 weeks, 6 weeks, 12 weeks (primary timepoint) post-operative
Primary outcome [3] 328933 0
Sphenoid sinus ostium measurement assessed by direct visualisation using nasal endoscopy
Timepoint [3] 328933 0
Intra-operative (day 0), 2 weeks, 6 weeks, 12 weeks (primary timepoint) post-operative
Secondary outcome [1] 399118 0
Post-operative prednisolone requirements as determined at post-operative in-person or telephone follow-up at 12 weeks
Timepoint [1] 399118 0
At the end of the 12 week post-operative period
Secondary outcome [2] 399119 0
Self-directed symptom based questionnaires (SNOT-22 questionnaire)
Timepoint [2] 399119 0
2 weeks, 6 weeks, 12 weeks post-operative

Eligibility
Key inclusion criteria
1. Patients with symptoms of chronic rhinosinusitis (nasal discharge, post-nasal drip, nasal obstruction, facial pain, pressure, anosmia) that have been persistent for great than 3 months AND
2. 18 years of age or over AND
3. Are able to give written informed consent AND
4. Are indicated to undergo endoscopic sinus surgery and willing AND
5. Can commit to return to clinic for 2 week, 6 week and 12 week post-operative endoscopic examination (as per standard of care)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Allergy to shellfish
2. Pregnancy or breastfeeding
3. Hepatitis or blood disorders
4. Allergy to steroids
5. COVID-19 positive

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)
Allocation to either treatment group (Chitosan/Dextran vs PureRegen) will be concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of groups for the sealed opaque envelopes will be performed using simple randomised using a computer software algorithm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
An A-priori power calculation was run to determine the minimum sample size for statistical analysis. The sample size calculation assumes a 95% confidence interval, a desired power level of 0.80, and a small effect size between treatment groups in each sinus type (Cohen's d=0.3). Using these assumptions, the sample size required for this analysis was estimated to be 25. ASsuming a dropout rate of 20% (and assuming that a patient dropping out at any point of the study will lead to removal of all their measurements from the study), this gives a desired recruitment number of 31.

Superiority analysis of measured outcomes will be conducted be a Repeat Measured ANOVA (RM-ANOVA), where 2 treatment groups are compared against 3 sinus positions and 4 repeated time measurements. The independent categorical variables will be "treatment type," "sinus type" and "time,"" with the dependent variable being the ostial measurement. Interaction effects between treatment type, sinus type and time will be investigated for significance in the RM-ANOVA model. Post-hoc adjusted student t-tests will compare the mean difference between the treatments for each sinus type at each time measurement with a 95% confidence interval. The standard error of these t-tests will also be adjusted for paired samples, as the independece of observations does not hold (there are two observations per person at each time for each sinus position that are being tested). All t-tests will be 2 tailed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
1/04/2022
Actual
Date of last data collection
Anticipated
1/07/2022
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20126 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 20127 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [3] 20128 0
North Shore Private Hospital - St Leonards
Recruitment hospital [4] 20129 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 34837 0
2139 - Concord
Recruitment postcode(s) [2] 34838 0
2076 - Wahroonga
Recruitment postcode(s) [3] 34839 0
2065 - St Leonards
Recruitment postcode(s) [4] 34840 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 308636 0
University
Name [1] 308636 0
University of Adelaide
Country [1] 308636 0
Australia
Primary sponsor type
Individual
Name
Yuresh Naidoo
Address
The ENT Centre
Suite 12, Level 1, The Madison Building
25-29 Hunter Street
Hornsby NSW 2077
Country
Australia
Secondary sponsor category [1] 309507 0
Individual
Name [1] 309507 0
Michael Lee
Address [1] 309507 0
Institute of Academic Surgery - RPA
145-147 Missenden Road Camperdown
Corner of Missenden Rd & Carillon Ave
Country [1] 309507 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308562 0
Concord Hospital - Human Research Ethics Committee
Ethics committee address [1] 308562 0
Ethics committee country [1] 308562 0
Australia
Date submitted for ethics approval [1] 308562 0
24/03/2021
Approval date [1] 308562 0
15/04/2021
Ethics approval number [1] 308562 0
CH62/6/2020-143

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111146 0
A/Prof Yuresh Naidoo
Address 111146 0
The ENT Centre
Suite 12, Level 1, The Madison Building
25-29 Hunter Street
Hornsby NSW 2077
Country 111146 0
Australia
Phone 111146 0
+61294773717
Fax 111146 0
Email 111146 0
yuresh@med.usyd.edu.au
Contact person for public queries
Name 111147 0
Michael Lee
Address 111147 0
Institute of Academic Surgery - RPA
145-147 Missenden Road Camperdown NSW 2050
Corner of Missenden Rd & Carillon Ave
Country 111147 0
Australia
Phone 111147 0
+61 404422321
Fax 111147 0
Email 111147 0
michael.lee@health.nsw.gov.au
Contact person for scientific queries
Name 111148 0
Michael Lee
Address 111148 0
Institute of Academic Surgery - RPA
145-147 Missenden Road Camperdown
Corner of Missenden Rd & Carillon Ave
Country 111148 0
Australia
Phone 111148 0
+61 404422321
Fax 111148 0
Email 111148 0
michael.lee@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected will be de-identified and used only for the purposes of this study as per the patient information consent forms.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12736Study protocol    382022-(Uploaded-02-08-2021-11-32-01)-Study-related document.docx
12737Ethical approval    382022-(Uploaded-02-08-2021-11-32-08)-Study-related document.pdf
12738Informed consent form    382022-(Uploaded-02-08-2021-11-32-21)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.