Effect of Chitodex Gel in Tympanoplasty Surgery
Recruiting now · Not applicable
Conditions studied: Tympanic Membrane Perforation, Tympanic Membrane Inflammation, Surgery, Otitis Media
In brief
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.
Key facts
- Study ID
- NCT06260618
- Run by
- Central Adelaide Local Health Network Incorporated
- People needed
- 44
- Starts
- 2021-11-20
- Expected to finish
- 2025-05-13
- Last updated by the study team
- 2024-11-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op
You may not qualify if…
- 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
- Contra-indications for MRI
Where it is running
- The Queen Elizabeth Hospital — Adelaide, South Australia, Australia (enrolling)
- The Memorial Hospital — North Adelaide, South Australia, Australia (enrolling)
Full record on ClinicalTrials.gov
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