ANZCTR - Registration

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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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chronic rhinosinusitis

Condition category

Condition code

Surgery

Other surgery

Inflammatory and Immune System

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]

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]

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]

2 weeks, 1 month, 2 months and 3 months post operatively.

Secondary outcome [1]

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]

Preoperatively (baseline), day 7, 14 and 28 postoperatively.

Secondary outcome [2]

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]

1 week, 2 weeks, 4 weeks postoperatively

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Gosford Hospital - Gosford

Recruitment hospital [2]

Gosford Private Hospital - Gosford

Recruitment postcode(s) [1]

2250 - Gosford

Recruitment postcode(s) [2]

2250 - North Gosford

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Gosford Hospital - In kind funding - staff time

Address [1]

Gosford Hospital
Holden Street
Gosford NSW 2250

Country [1]

Australia

Primary sponsor type

Hospital

Name

Gosford Hospital

Address

Gosford Hospital
Holden Street
Gosford NSW 2250

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Hunter New England HREC

Ethics committee address [1]

Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/01/2021

Approval date [1]

Ethics approval number [1]

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

Dr Michael Zhang

Address

Department of Otolaryngology, Head and Neck Surgery
F5 Surgical Offices - Otolaryngology Head and Neck Surgery
Gosford Hospital
Holden Street
Gosford, NSW 2250

Country

Australia

Phone

+61 414658119

Fax

michael.zhang@outlook.com.au

Contact person for public queries

Name

Michael Zhang

Address

F5 Surgical Offices - Otolaryngology Head and Neck Surgery
Gosford Hospital
Holden Street
Gosford, NSW 2250

Country

Australia

Phone

+61 2 4320 2111

Fax

michael.zhang4@health.nsw.gov.au

Contact person for scientific queries

Name

Michael Zhang

Address

F5 Surgical Offices - Otolaryngology Head and Neck Surgery
Gosford Hospital
Holden Street
Gosford, NSW 2250

Country

Australia

Phone

+61 2 4320 2111

Fax

michael.zhang4@health.nsw.gov.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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9881	Study protocol					381008-(Uploaded-12-01-2021-10-51-55)-Study-related document.docx

Results publications and other study-related documents

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No additional documents have been identified.

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