Tympanic Membrane PerforationNCT06260618
Effect of Chitodex Gel in Tympanoplasty Surgery
A study testing Gelfoam and Chitodex in people with Tympanic Membrane Perforation and Tympanic Membrane Inflammation, run by Central Adelaide Local Health Network Incorporated at 2 sites in Australia.
Trial summary
The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanic Membrane Perforation, Tympanic Membrane Inflammation, Surgery
- What is being tested?
- Gelfoam and Chitodex
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesAustralia
- Study dates
- 20 Nov 2021to 13 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND
- Are indicated to undergo closure of the perforation via tympanoplasty surgery
- OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae
- OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma
- Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND
Show all 9Show fewer
- Are 18 years of age or over AND
- Are able to give written informed consent AND
- Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op
Who cannot join
- Operative ear is the better or only hearing ear
- The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination
- dysfunction during otoscopic and tympanometric examination
- Known allergy to shellfish or ciprofloxacin antibiotics
- Pregnant or breastfeeding
- Hepatitis, HIV or any blood disorders
- COVID-19 positive patients
- Contra-indications for MRI
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Prof Peter John Wormald, MD, +61 8 8222 7158, pjwormald@gmail.com
Emma Barry, BSc (Hons), +61 8 8222 7158, emma.barry@adelaide.edu.au
- Recruiting
The Memorial Hospital
North Adelaide, South Australia, 5006
Prof Peter John Wormald, MD, +61 8 8222 7158, prwormald@gmail.com
About this study
Official 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
The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.
Read the detailed description
The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP), or ossiculoplasty due to ossicular chain disruption and its sequelae, or mastoidectomy for Chromin Otitis Media (COM) or its sequelae eg cholesteatoma.
The investigators aim to compare the success rates of middle ear surgery between the two products. The ultimate goal is to identify the ME packing agent-of-choice to ensure TMP closure as well as minimal inflammation of the middle ear mucosa. The most critical measure of success during tympanoplasty surgery is the closure of a chronic, pre-existing TMP. As such, the primary outcome will be a measure of tympanic membrane closure. This is performed under direct vision during routine post-operative surveillance via the use of either a hand-held otoscope or an operating otologic microscope. The investigators will perform this check at 4 distinct time-points: 2 and 6 weeks post-op, 3 months post-op and 6 months post-op.
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.
Fidelity of the interventions is measured in several ways by the surgeon at the end of the operation. A good seal for the graft is always assessed for by the surgeon prior to completing any tympanoplasty. This is determined via any evidence of air escape from the middle ear when palpating the tympanic membrane and graft at the end of the procedure. A good seal indicates a well-positioned graft. The surgeon's operative notes will indicate this. The investigators will also obtain endoscopic images and videos at the end of procedure to assess positioning of the graft.
- Being tested
- Gelfoam, Chitodex
- Keywords
- tympanic membrane, surgery, single blinded, chitogel, chitosan-dextran, otitis media, gelfoam, medical device, chitodex, myringoplasty, mastoidectomy, ossiculoplasty
- Medical subject headings
- Tympanic Membrane Perforation, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelfoamDevice
Also called Gelfoam® absorbable gelatin compressed sponge, USP
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.
ChitodexDevice
Also called Chitosan-Dextran, Chitogel Endoscopic Sinus Surgery Kit
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.
- 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.
- The second component Chitosan Succinamide (C), is a liquid and is also supplied sterile.
| Study group | Role | What they receive |
|---|---|---|
| Gelfoam Arm | Active comparator | 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. Receives: Device: Gelfoam |
| Chitodex Arm | Experimental | 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. Receives: Device: Chitodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with tympanic membrane closure
tympanic membrane closure will be assessed via otoscopy (images will be captured via the otoscopic equipment)
Measured: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
rate of tympanic membrane closure
Time taken for tympanic membrane to close, assessed by otoscopy (images will be captured via the otoscopic equipment)
Measured: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Secondary outcomes (6)
Number of participants with improved hearing
An audiogram will be used for assessment of hearing. It measures hearing thresholds in decibels over a range of noise frequencies from 200Hz up to 8000Hz. It is always performed in a sound-proof room with over ear headphones
Measured: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Number of participants with improved eardrum function
Eardrum function will be tested by Tympanometry, which tests how well the eardrum moves. The audiologist will put a small probe into the ear. A small device attached to the probe will push air into the ear. The output from the probe is translated to a graph called a tympanogram.
Measured: Pre-operatively, and 3 months and 6 months post-operatively
Ease of use of product compared to active comparator - surgeon feedback
Ease of use of product will be assessed via surgeon's feedback
The ease of which to place the packing material within the anterior mesotympanum will be assessed, as well as the ease with which adequate graft positioning was obtained at the end of surgery. This will be done on a 7-point Likert scale with 1 been very difficult and 7 being very easy to use. After the surgeon has finished the surgery, the trial staff will collect this score from the surgeon within 24 hours of the surgery.
Measured: Once, on day of surgery (within 6 hours post-operatively)
Time taken to complete surgery
Start and finish times for all surgeries is clocked into the hospital peri-operative software by the nursing staff in real time. This is a routine part of modern peri-operative care. These records can be retrieved to establish the total operating time of each surgery.
Measured: Once, for the duration of the operation (hours)
Number of Participants with improved quality of life
This will be determined by a participant subjective symptom score/questionnaire, called the Modified Chronic Otitis Media Outcomes Test (modCOMOT-8 test).
This is a modified/shorter version of a validated test that was designed for the current study, as there is no current validated questionnaire to assess post-tympanoplasty subjective symptoms, The original test, The Chronic Otitis Media Outcomes Test (COMOT-15 test) has been published widely.
The modCOMOT-8 test includes a score for (left and right); hearing, ear discharge, ear pain, ear fullness, tinnitus (ringing in the ears), vertigo, overall ear health, overall impact on quality of life. The total possible score ranges from 0 to 160, where the lower the score, the better the outcome.
Measured: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Clearance of Chitodex gel from middle ear
Clearance of Chitodex gel or gelfoam from middle ear will be assessed by Magnetic resonance imaging (MRI). This will determination of clearance the packing agent or of any inflammatory or infectious processes.
Measured: 4 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start20 Nov 2021
- Primary completion13 May 2025 (estimated)
- Study completion13 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomised clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Adelaide Local Health Network Incorporated
- Sponsor type
- Other government
- Collaborators
- University of Adelaide
- Responsible party
- Principal investigator, Peter-John Wormald, Central Adelaide Local Health Network Incorporated
- Investigators
- Prof Peter-John Wormald, MD, Principal investigator, Central Adelaide Local Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260618
- Sponsor's protocol ID
- 2021/HRE00065
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06260618
- Acronym / sponsor ID
- 2021/HRE00065
- Keywords
- tympanic membrane, surgery, single blinded, chitogel, chitosan-dextran, otitis media, gelfoam, medical device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Central Adelaide Local Health Network IncorporatedOther government
- Collaborators
- University of Adelaide
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 13 May 2025 (estimated)
- Study completion
- 13 May 2025 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.
Detailed description
The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP), or ossiculoplasty due to ossicular chain disruption and its sequelae, or mastoidectomy for Chromin Otitis Media (COM) or its sequelae eg cholesteatoma.
The investigators aim to compare the success rates of middle ear surgery between the two products. The ultimate goal is to identify the ME packing agent-of-choice to ensure TMP closure as well as minimal inflammation of the middle ear mucosa. The most critical measure of success during tympanoplasty surgery is the closure of a chronic, pre-existing TMP. As such, the primary outcome will be a measure of tympanic membrane closure. This is performed under direct vision during routine post-operative surveillance via the use of either a hand-held otoscope or an operating otologic microscope. The investigators will perform this check at 4 distinct time-points: 2 and 6 weeks post-op, 3 months post-op and 6 months post-op.
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.
Fidelity of the interventions is measured in several ways by the surgeon at the end of the operation. A good seal for the graft is always assessed for by the surgeon prior to completing any tympanoplasty. This is determined via any evidence of air escape from the middle ear when palpating the tympanic membrane and graft at the end of the procedure. A good seal indicates a well-positioned graft. The surgeon's operative notes will indicate this. The investigators will also obtain endoscopic images and videos at the end of procedure to assess positioning of the graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Gelfoam Arm | Active comparator | Device: GelfoamThe 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. |
| Chitodex Arm | Experimental | Device: ChitodexChitosan-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae
- OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma
- Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND
- Are 18 years of age or over AND
Key exclusion criteria (8 listed)
- Operative ear is the better or only hearing ear
- The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination
- dysfunction during otoscopic and tympanometric examination
- Known allergy to shellfish or ciprofloxacin antibiotics
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GelfoamAlso: Gelfoam® absorbable gelatin compressed sponge, USPGELFOAM 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. | Device | Gelfoam Arm |
| ChitodexAlso: Chitosan-Dextran, Chitogel Endoscopic Sinus Surgery KitThe 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. | Device | Chitodex Arm |
Primary outcome
Number of participants with tympanic membrane closure
Time frame: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
tympanic membrane closure will be assessed via otoscopy (images will be captured via the otoscopic equipment)
rate of tympanic membrane closure
Time frame: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Time taken for tympanic membrane to close, assessed by otoscopy (images will be captured via the otoscopic equipment)
6 secondary outcomes
Number of participants with improved hearing
Time frame: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Number of participants with improved eardrum function
Time frame: Pre-operatively, and 3 months and 6 months post-operatively
Ease of use of product compared to active comparator - surgeon feedback
Time frame: Once, on day of surgery (within 6 hours post-operatively)
Time taken to complete surgery
Time frame: Once, for the duration of the operation (hours)
Number of Participants with improved quality of life
Time frame: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Clearance of Chitodex gel from middle ear
Time frame: 4 weeks post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Peter-John Wormald, MD principal investigator
Central Adelaide Local Health Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelfoam and Chitodex in people with Tympanic Membrane Perforation and Tympanic Membrane Inflammation, run by Central Adelaide Local Health Network Incorporated at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Peter-John Wormald, MD, (+61 8 82227158, pjwormald@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with tympanic membrane closure (time frame: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.