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Trial registered on ANZCTR


Registration number
ACTRN12621000381886p
Ethics application status
Submitted, not yet approved
Date submitted
26/11/2020
Date registered
6/04/2021
Date last updated
6/04/2021
Date data sharing statement initially provided
6/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the efficacy and safety of steroid-impregnated self-crosslinked hyaluronic acid (PureRegen®) and steroid-impregnated bioabsorbable polyurethane foam (Nasopore®) in adults undergoing functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis (CRS): a randomised controlled trial.
Scientific title
Comparison of the efficacy and safety of steroid-impregnated self-crosslinked hyaluronic acid (PureRegen®) and steroid-impregnated bioabsorbable polyurethane foam (Nasopore®) in adults undergoing functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis (CRS): a randomised controlled trial.
Secondary ID [1] 302882 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic rhinosinusitis 319880 0
Condition category
Condition code
Surgery 317818 317818 0 0
Other surgery
Inflammatory and Immune System 319206 319206 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the outcomes of the placement of the below devices following functional endoscopic sinus surgery (FESS).
- Steroid-impregnated Nasopore® (bioabsorbable polyurethane foam)
- Steroid impregnated PureRegen® (self-crosslinked hyaluronic acid sinus dressing)

The placement of the device will be placed to medialise the middle turbinate in both nasal cavities at the conclusion of the surgical procedure by the surgeon, but whilst patients are still under general anaesthesia. These will be left in place for 14 days, after which they will either be fully absorbed or the remnants suctioned out in outpatient clinic. Steroid used will be 1mg of budesonide on either side.
Intervention code [1] 319169 0
Treatment: Devices
Comparator / control treatment
This study will compare the outcomes of the placement of the below devices following functional endoscopic sinus surgery (FESS).
- Steroid impregnated Nasopore® (bioabsorbable polyurethane foam)
- Steroid infused PureRegen® (self-crosslinked hyaluronic acid sinus dressing) - comparator

Both products are FDA and TGA approved for use in Australia and USA for these purposes, and are currently standard practice across Australia.
Control group
Active

Outcomes
Primary outcome [1] 325841 0
The primary outcome of this study is determining which device confers the greatest endoscopic post-FESS benefit at 2 weeks, 1 month, 2 months and 3 months via validated scoring systems such as PeriOperative Sinus Endoscopy Score and Lund-Kennedy Scores off recorded endoscopic video at clinic followups
Timepoint [1] 325841 0
2 weeks, 1 month, 2 months and 3 months post operatively.
Secondary outcome [1] 389293 0
Ascertain whether there are any systemic effects of steroid-impregnated Nasopore or steroid-impregnated PureRegen.

This composite secondary outcome will be assessed with serial measurement of early morning serum ACTH and serum cortisol (preoperatively, day 7, 14 and 28 postoperatively).
Timepoint [1] 389293 0
Preoperatively (baseline), day 7, 14 and 28 postoperatively.
Secondary outcome [2] 389294 0
To assess whether there are any ocular effects (i.e. intraocular hypertension) of steroid-impregnated Nasopore and steroid-impregnated PureRegen via serial tonometry measurements (preoperatively, day 1 postoperatively, day 7, 14 and 28 postoperatively).
Timepoint [2] 389294 0
1 week, 2 weeks, 4 weeks postoperatively
Secondary outcome [3] 389295 0
Comparison of subjective post-operative benefit between steroid-impregnated Nasopore and steroid-impregnated PureRegen via serial SinoNasal Outcome Test (SNOT-22) patient reported symptom questionnaire.
Timepoint [3] 389295 0
Preoperatively, 2 weeks, 1 month, 2 months, 3 months postoperatively.

Eligibility
Key inclusion criteria
1) CT Lund-Mackay score was greater and equal to 1, AND
2) Minimum trial of at least eight weeks’ duration of a topical intranasal corticosteroid, AND
3) Short course of systemic corticosteroid (CRSwNP) OR either a short-course of a broad spectrum / culture-directed systemic antibiotic OR the use of a prolonged course of systemic low-dose anti-inflammatory antibiotic (CRSsNP)
4) Post-medical treatment total SNOT-22 score greater than or equal to 20.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Immunodeficiency
- Cystic fibrosis
- Rhinologic granulomatous disease
- Use of oral/nasal steroids from 30 days preoperatively to 30 days postoperatively
- Previous sinus surgery
- Aspirin intolerance
- Asthma
- Mucociliary disorder
- History of Glaucoma
- Unable to provide informed consent
- Unable to commit to attending follow-up appointments

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)
Randomisation will be performed using a computer-generated randomisation sequence and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a computer-generated randomisation sequence and sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be presented in the mean +/- standard deviation format. Differences between intervention group will be assessed as per the Mann-Whitney U (Wilcoxin Rank Sum) test with a 95% confidence interval, with statistical significance defined as a p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
Date of last participant enrolment
Anticipated
27/08/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18113 0
Gosford Hospital - Gosford
Recruitment hospital [2] 18114 0
Gosford Private Hospital - Gosford
Recruitment postcode(s) [1] 32106 0
2250 - Gosford
Recruitment postcode(s) [2] 32107 0
2250 - North Gosford

Funding & Sponsors
Funding source category [1] 307301 0
Hospital
Name [1] 307301 0
Gosford Hospital - In kind funding - staff time
Country [1] 307301 0
Australia
Primary sponsor type
Hospital
Name
Gosford Hospital
Address
Gosford Hospital
Holden Street
Gosford NSW 2250
Country
Australia
Secondary sponsor category [1] 307942 0
None
Name [1] 307942 0
N/A
Address [1] 307942 0
N/A
Country [1] 307942 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307398 0
Hunter New England HREC
Ethics committee address [1] 307398 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 307398 0
Australia
Date submitted for ethics approval [1] 307398 0
29/01/2021
Approval date [1] 307398 0
Ethics approval number [1] 307398 0

Summary
Brief summary
Chronic rhinosinusitis (CRS) affects between 12 and 15.2% of the adult population in the United States, with direct and indirect costs of management exceeding twelve billion US dollars annually. In patients whose CRS is refractory to pharmacological or medical management, functional endoscopic sinus surgery (FESS) has become a well-recognised, established and safe surgical option to re-open sinus ostia, restoring the physiological drainage pathways of the sinuses and facilitating mucociliary clearance. This enables the thorough application of topical therapies to the sinonasal mucosa, increasing the likelihood of successful medical management.

The efficacy and desirable outcomes of FESS can be reduced by postoperative inflammation, polyp recurrence and adhesions. Topical steroids in the form of nasal sprays are well established in preventing these adverse outcomes and as such, there has been considerable recent investigation of intraoperative placement of bioabsorbable products to both improve and increase the longevity of the desired postoperative outcomes, thereby reducing rates of revision FESS.

To our knowledge, whether steroid-impregnated bioabsorbable synthetic polyurethane foam (Nasopore®) confers any objective or subjective postoperative benefit over steroid-impregnated self-crosslinked hyaluronic acid (PureRegen®), and the systemic and ocular safety of their use have not yet been studied.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107090 0
Dr Michael Zhang
Address 107090 0
Department of Otolaryngology, Head and Neck Surgery
F5 Surgical Offices - Otolaryngology Head and Neck Surgery
Gosford Hospital
Holden Street
Gosford, NSW 2250
Country 107090 0
Australia
Phone 107090 0
+61 414658119
Fax 107090 0
Email 107090 0
[email protected]
Contact person for public queries
Name 107091 0
Michael Zhang
Address 107091 0
F5 Surgical Offices - Otolaryngology Head and Neck Surgery
Gosford Hospital
Holden Street
Gosford, NSW 2250
Country 107091 0
Australia
Phone 107091 0
+61 2 4320 2111
Fax 107091 0
Email 107091 0
[email protected]
Contact person for scientific queries
Name 107092 0
Michael Zhang
Address 107092 0
F5 Surgical Offices - Otolaryngology Head and Neck Surgery
Gosford Hospital
Holden Street
Gosford, NSW 2250
Country 107092 0
Australia
Phone 107092 0
+61 2 4320 2111
Fax 107092 0
Email 107092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9881Study protocol    381008-(Uploaded-12-01-2021-10-51-55)-Study-related document.docx



Results publications and other study-related documents

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