Actively Recruiting
Effect of Chitodex Gel in Tympanoplasty Surgery
Led by Central Adelaide Local Health Network Incorporated · Updated on 2024-11-13
44
Participants Needed
2
Research Sites
181 weeks
Total Duration
On this page
Sponsors
C
Central Adelaide Local Health Network Incorporated
Lead Sponsor
U
University of Adelaide
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Chitodex Gel in Tympanoplasty Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with otoscopic evidence of tympanic membrane perforation confirmed by tympanometry (Type B tympanogram with elevated external auditory canal volume)
- Tympanic membrane perforation associated with at least 15 dB conductive hearing loss on the affected side
- Candidates for tympanoplasty surgery to close tympanic membrane perforation
- OR candidates for ossiculoplasty due to ossicular chain disruption and related conditions
- OR candidates for mastoidectomy for chronic otitis media or its sequelae such as cholesteatoma
- Healthy, dry middle ear mucosal cavities at time of surgery
- Adults aged 18 years or older
- Able to provide written informed consent
- Willing to attend post-operative assessments at 2 and 6 weeks, 3 months, and 6 months after surgery
You will not qualify if you...
- Operative ear is the better or only hearing ear
- Presence of cholesteatoma or other middle ear tumor detected during otoscopic examination
- Dysfunction observed during otoscopic and tympanometric examinations
- Known allergy to shellfish or ciprofloxacin antibiotics
- Pregnant or breastfeeding individuals
- History of hepatitis, HIV, or any blood disorders
- Currently COVID-19 positive
- Contraindications for MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Actively Recruiting
2
The Memorial Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
Research Team
P
Prof Peter-John Wormald, MD,
CONTACT
E
Emma Barry, BSc (Hons)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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