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Trial registered on ANZCTR


Registration number
ACTRN12615000276550
Ethics application status
Approved
Date submitted
4/03/2015
Date registered
24/03/2015
Date last updated
24/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of chitosan-dextran (Chitodex) gel with budesonide and ropivacaine on pain and wound healing following endoscopic sinus surgery
Scientific title
The effect of chitosan-dextran (Chitodex) gel with budesonide and ropivacaine on pain and wound healing following endoscopic sinus surgery in patients with chronic rhinosinusitis.
Secondary ID [1] 286314 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis 294413 0
Condition category
Condition code
Respiratory 294722 294722 0 0
Other respiratory disorders / diseases
Anaesthesiology 294766 294766 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that is being trialled is a gel complex consisting of Chitosan-Dextran gel plus Budesonide plus Ropivacaine. 10mLs of this complex will be applied to the sinonasal cavity immediately following endoscopic sinus surgery by the surgeon. The complex will include the Chitosan-Dextran gel (5% Succinyl-Chitosan & 300mg Dextran-aldehyde), 1mL of 1% Ropivacaine (10mg/mL), 2mL of Budesonide (1mg). This complex will be applied twice to each patient (Once for each sinus side).
Intervention code [1] 291361 0
Treatment: Drugs
Comparator / control treatment
The comparative treatment is the same gel complex including dosages without the addition of ropivacaine. Therefore Chitosan-Dextran gel plus Budesonide will be applied to each sinus side, without the addition of Ropivacaine. It will be applied to the sinonasal cavity immediately following endoscopic sinus surgery by the surgeon.
Control group
Active

Outcomes
Primary outcome [1] 294485 0
Pain after endoscopic sinus surgery as determined by numerical rating scale.
Timepoint [1] 294485 0
Pain scores will be collected at pre-determined time points for a week following the surgery.

The time-points are as follows:
- 2 hours after the procedure
- 12 hours after the procedure
- 24 hours after the procedure
- 2 days after the procedure
- 3 days after the procedure
- 4 days after the procedure
- 5 days after the procedure
- 6 days after the procedure
- 7 days after the procedure
Secondary outcome [1] 313434 0
Presence and magnitude of adhesions using an ordinal scale following endoscopic sinus surgery, as determined by endoscopic video recordings of the sinuses by the treating surgeon.
Timepoint [1] 313434 0
Endoscopic video recording will occur at 2 weeks, 8 weeks and 3 months following endoscopic sinus surgery.

Eligibility
Key inclusion criteria
Patients with chronic rhinosinusitis undergoing endoscopic sinus surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnanct and/or breastfeeding.
Allergy or previous adverse reaction to shellfish, anaesthetics or corticosteroids.

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)
Patients will be recruited and randomised by the associate investigator, via the use of sealed opaque envelopes. Allocation concealment will only apply to the treating surgeon responsible for administering the gel complex to the sinuses. The surgeon will continue to be blinded to the treatment for the entire follow-up period (3 months). The associate investigator cannot be blinded to the treatment as they are responsible for mixing of the gel with the active medications.
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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2015
Actual
18/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290886 0
University
Name [1] 290886 0
The Department of ENT, University of Adelaide
Country [1] 290886 0
Australia
Primary sponsor type
University
Name
The Department of ENT, University of Adelaide
Address
28 Woodville road, Woodville South, SA, 5011
Country
Australia
Secondary sponsor category [1] 289568 0
None
Name [1] 289568 0
Address [1] 289568 0
Country [1] 289568 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292488 0
Human Research Ethics Committee
Ethics committee address [1] 292488 0
The Queen Elizabeth Hospital
Ethics: DX465101
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 292488 0
Australia
Date submitted for ethics approval [1] 292488 0
14/01/2015
Approval date [1] 292488 0
25/02/2015
Ethics approval number [1] 292488 0
HREC/15/TQEH/2

Summary
Brief summary
The purpose of this study is to further develop a nasal dressing for use after endoscopic sinus surgery. The gel being use is called Chitodex (Chitosan-Dextran gel) and has already been shown to be effective in controlling blood loss and reducing adhesions after endoscopic sinus surgery. The effectiveness and safety of the gel has been demonstrated in numerous human and animal trials.

We are trying to incorporate additional medications into the gel to further accentuate it's uses after endoscopic sinus surgery. The addition of budesonide has shown to reduce adhesions and inflammation after sinus surgery, thus reducing the failure rate of the operation and the chance a patient needs another procedure. This has been demonstrated in a clinical trial.

We hypothesise that the addition of a local anaesthetic to the gel, known as ropivacaine, will reduce the pain and discomfort that patients typically experience after endoscopic sinus surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55550 0
Prof Peter-John Wormald
Address 55550 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 55550 0
Australia
Phone 55550 0
+ 61 8 8222 7158
Fax 55550 0
Email 55550 0
[email protected]
Contact person for public queries
Name 55551 0
Aaron Rayan
Address 55551 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 55551 0
Australia
Phone 55551 0
+ 61 8 8222 7158
Fax 55551 0
Email 55551 0
[email protected]
Contact person for scientific queries
Name 55552 0
Peter-John Wormald
Address 55552 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 55552 0
Australia
Phone 55552 0
+ 61 8 8222 7158
Fax 55552 0
Email 55552 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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