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Effect of Chitodex Gel in Tympanoplasty Surgery

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Study details:

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). The investigators aim to compare the success rates of tympanoplasty 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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)

The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side

Are indicated to undergo closure of the perforation via tympanoplasty surgery

Demonstrate healthy, dry middle ear mucosal cavities at time of surgery

Are 18 years of age or over

Are able to give written informed consent

Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op

Exclusion criteria

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-11-20

Primary completion: 2024-05-13

Study completion finish: 2024-05-13

Study type

TREATMENT

Phase

Trial ID

NCT06260618

Intervention or treatment

DEVICE: Gelfoam

DEVICE: Chitodex

Conditions

• Tympanic Membrane Perforation
• Tympanic Membrane Inflammation
• Surgery
• Otitis Media

Image related to Tympanic Membrane Perforation

Condition: Tympanic Membrane Perforation, Tympanic Membrane Inflammation and more
DEVICE: Gelfoam and other drugs
Adelaide, South Australia, Australia and more
Sponsor: Central Adelaide Local Health Network Incorporated

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Find a site

Closest Location:

The Queen Elizabeth Hospital

Research sites nearby

Select from list below to view details:

The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
The Memorial Hospital
North Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.	DEVICE: 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.
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.	DEVICE: 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.

Participant Group/Arm

Intervention/Treatment

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.

DEVICE: 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.

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.

DEVICE: 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of participants with tympanic membrane closure	tympanic membrane closure will be assessed via otoscopy (images will be captured via the otoscopic equipment)	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)	Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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	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.	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.	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.	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.	Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively

Frequently Asked Questions

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References

Clinical Trials Gov: Effect of Chitodex Gel in Tympanoplasty Surgery