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Effect of Chitodex Gel in 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 procedures to close tympanic membrane perforations (TMP).
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
NA
Trial ID
NCT06260618
Intervention or treatment
DEVICE: Gelfoam
DEVICE: Chitodex
Conditions
- • Tympanic Membrane Perforation
- • Tympanic Membrane Inflammation
- • Surgery
- • Otitis Media
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
| DEVICE: Gelfoam
|
EXPERIMENTAL: Chitodex Arm
| DEVICE: Chitodex
|
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 |
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