Effect of Chitodex Gel in Tympanoplasty Surgery (NCT06260618) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Chitodex Gel in Tympanoplasty Surgery
Australia44 participantsStarted 2021-11-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with tympanic membrane closure
Timeframe: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
2
rate of tympanic membrane closure
Timeframe: Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively
Trial details
NCT IDNCT06260618
SponsorCentral Adelaide Local Health Network Incorporated