Effect of Chitodex Gel in Tympanoplasty Surgery

Launched by CENTRAL ADELAIDE LOCAL HEALTH NETWORK INCORPORATED · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new gel called Chitodex to see how well it works compared to a standard packing material called Gelfoam during tympanoplasty surgery. This surgery is performed to repair holes in the eardrum, known as tympanic membrane perforations, which can cause hearing loss and other issues. The researchers want to find out if using Chitodex gel can improve outcomes for patients undergoing this procedure.

To participate in the trial, you need to be at least 18 years old and have a confirmed perforation in your eardrum that is causing hearing loss. You also need to be able to attend follow-up appointments after your surgery. If you are pregnant, have certain ear conditions, or have specific health issues, you may not be eligible. If you do take part, you can expect to have your hearing and ear health monitored after the surgery to see how well the treatment works. This trial is currently looking for participants, and your involvement could help improve future treatments for ear problems!

Gender

ALL

Eligibility criteria

• 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