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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06260618




Registration number
NCT06260618
Ethics application status
Date submitted
31/01/2024
Date registered
15/02/2024

Titles & IDs
Public title
Effect of Chitodex Gel in Tympanoplasty Surgery
Scientific title
A Single-blinded Randomised Trial Evaluating the Efficacy of Chitosan-dextran (Chitodex) Gel Versus Gelfoam Sponge Instillation Within the Middle Ear and External Auditory Canal During Tympanoplasty Surgery
Secondary ID [1] 0 0
2021/HRE00065
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tympanic Membrane Perforation 0 0
Tympanic Membrane Inflammation 0 0
Surgery 0 0
Otitis Media 0 0
Condition category
Condition code
Ear 0 0 0 0
Other ear disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Gelfoam
Treatment: Devices - Chitodex

Active comparator: Gelfoam Arm - The current standard of care in middle ear packing material has been Gelfoam, Gelfoam is an absorbable gelatin sponge manufactured from denatured porcine skin. Generally, Gelfoam resides within the middle ear for 2 to 9 weeks prior to being degraded via phagocytosis.

A single Gelfoam sponge is divided into small pieces and used within the ear. One piece of Gelfoam can typically be cut into over 200 smaller pieces. The surgeon uses approximately 10 to 20 of these smaller pieces per surgery. Approx a third of the product is applied into the middle ear, as a support material for the graft. After graft suturing is complete, the remaining two thirds are applied into the external ear canal as a packing agent.

The surgeon administers the foam during the surgery as they would with the standard TMP repair surgery. The product comes in a sterile package to be opened and cut up by Scrub Nurse.

Experimental: Chitodex Arm - Chitosan-dextran gel is packaged within a syringe and has a cannula attached, much like the Gelfoam syringe system. Approx 3-5mL of product is applied during the surgery. Approx 2mL into the middle ear, as a support material for the graft. After graft suturing is complete, another 3mL (approx) is applied into the external ear canal as a packing agent. This is the same procedure as Gelfoam is currently used for this purpose.

The surgeon will administer the gel during the surgery as they would with the standard of care Gelfoam. The product comes in a sterile kit to be opened by Scrub Nurse.


Treatment: Devices: Gelfoam
GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine skin, Gelatin USP Granules and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids.

Treatment: Devices: Chitodex
The Chitogel Endoscopic Sinus Surgery Kit contains components and equipment for the preparation of a nasal gel to be applied to the sinus cavities via a supplied and specifically designed malleable cannula.

The Gel preparation will take approximately 30 minutes, so preparation must start sufficiently in advance of when the Gel is expected to be used in surgery.

Once the Gel has been prepared it should be applied to the sinus cavities on both sides within six hours using the malleable cannula supplied with the Kit.

The Gel must be prepared on a sterile surface following these instructions. There are two main components to the Gel.

1. Dextran Aldehyde (B), which is a dry powder, and is reconstituted into a liquid form through mixing the powder with a liquid Sodium Phosphate Buffer (A). Both of these components are supplied sterile.
2. The second component Chitosan Succinamide (C), is a liquid and is also supplied sterile.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with tympanic membrane closure
Timepoint [1] 0 0
Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Primary outcome [2] 0 0
rate of tympanic membrane closure
Timepoint [2] 0 0
Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Secondary outcome [1] 0 0
Number of participants with improved hearing
Timepoint [1] 0 0
Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Secondary outcome [2] 0 0
Number of participants with improved eardrum function
Timepoint [2] 0 0
Pre-operatively, and 3 months and 6 months post-operatively
Secondary outcome [3] 0 0
Ease of use of product compared to active comparator - surgeon feedback
Timepoint [3] 0 0
Once, on day of surgery (within 6 hours post-operatively)
Secondary outcome [4] 0 0
Time taken to complete surgery
Timepoint [4] 0 0
Once, for the duration of the operation (hours)
Secondary outcome [5] 0 0
Number of Participants with improved quality of life
Timepoint [5] 0 0
Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Secondary outcome [6] 0 0
Clearance of Chitodex gel from middle ear
Timepoint [6] 0 0
4 weeks post-operatively

Eligibility
Key inclusion criteria
1. Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram, with elevated EAC volume) AND

1. The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND
2. Are indicated to undergo closure of the perforation via tympanoplasty surgery
2. OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae
3. OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma
4. Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND
5. Are 18 years of age or over AND
6. Are able to give written informed consent AND
7. Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Operative ear is the better or only hearing ear
2. The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination
3. dysfunction during otoscopic and tympanometric examination
4. Known allergy to shellfish or ciprofloxacin antibiotics
5. Pregnant or breastfeeding
6. Hepatitis, HIV or any blood disorders
7. COVID-19 positive patients
8. Contra-indications for MRI

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


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/05/2025
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
The Memorial Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide

Funding & Sponsors
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network Incorporated
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Adelaide
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Prof Peter-John Wormald, MD
Address 0 0
Central Adelaide Local Health Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Prof Peter-John Wormald, MD,
Address 0 0
Country 0 0
Phone 0 0
+61 8 82227158
Fax 0 0
Email 0 0
pjwormald@gmail.com
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06260618