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 range18 Years
SexALL
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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
✓. Are 18 years of age or over AND
✓. Are able to give written informed consent AND
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
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