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โ† Trials
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Effect of Chitodex Gel in Tympanoplasty Surgery

RecruitingNAAges 18 Years - anyAllCentral Adelaide Local Health Network Incorporated
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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
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What it tests

  • Gelfoam
  • Chitodex
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Where

2 sites
The Queen Elizabeth Hospital
Adelaide, Australia
The Memorial Hospital
North Adelaide, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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