Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001336875p
Ethics application status
Not yet submitted
Date submitted
24/06/2021
Date registered
5/10/2021
Date last updated
17/04/2023
Date data sharing statement initially provided
5/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Chitogel versus Hydrogel on wound healing and patient experience following endosopic sinus surgery
Scientific title
A Randomised controlled study to evaluate the effect of Chitogel versus Hydrogel on wound healing and patient experience following endosopic sinus surgery
Secondary ID [1] 304177 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic rhinosinusitis
 322539 0
endoscopic sinus surgery 323131 0
Condition category
Condition code
Surgery 320168 320168 0 0
Other surgery
Respiratory 320708 320708 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chitogel is a postoperative hydrogel nasal dressing that can be applied to sinuses after endoscopic sinus surgery. The hydrogel is made by combining Chitosan, Dextran and Glycerol. Chitogel has been shown to be an effective haemostatic nasal packing following endoscopic sinus surgery which reduces adhesion formation and stenosis of sinus ostia. It has also been shown to promote healing up to even 12 months following surgery, as demonstrated by reduced oedema, granulation and pus formation when compared to no packing.

The Chitogel is applied endonasally once, by the operating ear, nose and throat surgeon, at the end of surgery upon completion of the procedure. The gel comes in two components which are combined according to producer instruction manual. The gel is applied to the sinus cavity using a syringe and malleable cannula. 5-10mL will be applied, the same as the amount of Hydrogel (comparator) used. Endoscopic sinus surgery on average will take approximately 2 hours. Theatre staff will monitor that the application protocol is followed.
Intervention code [1] 320968 0
Treatment: Devices
Intervention code [2] 321372 0
Treatment: Surgery
Comparator / control treatment
Hydrogel (PureRegen Gel Sinus) is an injectable gel dressing used after endoscopic sinus surgery to improve mucosal healing. PureRegen Gel SINUS is formulated from crosslinked hyaluronic acid, purely from bacterial fermentation and contains no animal components.

The Hydrogel is applied endonasally once, by the operating ear, nose and throat surgeon, at the end of surgery upon completion of the procedure. The gel is applied to the sinus cavity using a syringe and malleable cannula. 5-10mL will be applied; the same as the amount of Chitogel (intervention) used. Endoscopic sinus surgery on average will take approximately 2 hours. Theatre staff will monitor that the application protocol is followed.
Control group
Active

Outcomes
Primary outcome [1] 328050 0
Post operative endoscopic degree of adhesion
Timepoint [1] 328050 0
2 weeks and 3 months post intervention commencement
Primary outcome [2] 328523 0
Post operative endoscopic degree of crusting
Timepoint [2] 328523 0
2 weeks and 3 months (primary) post intervention commencement
Primary outcome [3] 328529 0
Post operative endoscopic degree of granulations
Timepoint [3] 328529 0
2 weeks and 3 months (primary) post intervention commencement
Secondary outcome [1] 399335 0
Post operative endoscopic degree of mucosal oedema
Timepoint [1] 399335 0
2 weeks and 3 months post intervention commencement
Secondary outcome [2] 399336 0
Post operative endoscopic evidence of infection
Timepoint [2] 399336 0
2 weeks and 3 months post intervention commencement
Secondary outcome [3] 400306 0
Patient experience will be assessed with a subjective symptom score using the Sino–Nasal Outcome Test (SNOT–22)
Timepoint [3] 400306 0
3 months post commencement of intervention

Eligibility
Key inclusion criteria
Patients undergoing bilateral Functional ESS for CRS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to shellfish
Pregnancy/breast feeding
Previous sinus surgery

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Ethical approval not obtained
Date of first participant enrolment
Anticipated
28/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 23917 0
New Zealand
State/province [1] 23917 0

Funding & Sponsors
Funding source category [1] 308553 0
Hospital
Name [1] 308553 0
North Shore Hospital
Country [1] 308553 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore Hospital
Address
124 Shakespeare Road, Takapuna Auckland 0620
Country
New Zealand
Secondary sponsor category [1] 309914 0
None
Name [1] 309914 0
Address [1] 309914 0
Country [1] 309914 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308497 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 308497 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 308497 0
New Zealand
Date submitted for ethics approval [1] 308497 0
11/03/2022
Approval date [1] 308497 0
Ethics approval number [1] 308497 0

Summary
Brief summary
Endoscopic Sinus Surgery (ESS) has a crucial role in the management of chronic rhinosinusitis (CRS), however post-operative scaring and adhesion is a significant cause of surgical failure. Chitosan-Dextran Gel (Chitogel) has been shown to be an effective haemostatic nasal packing following ESS which reduces adhesion formation and stenosis of sinus ostia. It has also been shown to promote healing up to even 12 months following surgery, as demonstrated by reduced oedema, granulation and pus formation when compared to no packing. The purpose of this study is to evaluate the effect of Chitogel against the current standard of nasal packing being used; Hydrogel (PureRegen Gel Sinus), on post-operative wound healing and patient experience.

We will compare the effect of Chitogel with hydrogel (PureRegen Gel Sinus) being used at our institution. Our hypothesis is that use of Chitogel will yield different endoscopic appearances of the sinuses at post operative 2-week, and 3-month follow up checks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110910 0
Dr Kevin Zheng
Address 110910 0
2/23 Ruawai Road,
Mount Wellington
Auckland

North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road, Takapuna, Auckland 0620
Country 110910 0
New Zealand
Phone 110910 0
+642102648578
Fax 110910 0
Email 110910 0
[email protected]
Contact person for public queries
Name 110911 0
Dr Kevin Zheng
Address 110911 0
2/23 Ruawai Road,
Mount Wellington
Auckland

North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road, Takapuna, Auckland 0620
Country 110911 0
New Zealand
Phone 110911 0
+642102648578
Fax 110911 0
Email 110911 0
[email protected]
Contact person for scientific queries
Name 110912 0
Dr Kevin Zheng
Address 110912 0
2/23 Ruawai Road,
Mount Wellington
Auckland

North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road, Takapuna, Auckland 0620
Country 110912 0
New Zealand
Phone 110912 0
+642102648578
Fax 110912 0
Email 110912 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?

No Supporting Document Provided



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.