Comparing Chitodex Gel and Gelfoam in Ear Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of Chitosan-dextran (Chitodex) gel against the standard packing agent Gelfoam during tympanoplasty, ossiculoplasty, and mastoidectomy procedures. The focus is on evaluating the success rates of tympanic membrane closure and minimizing inflammation in the middle ear. Participants will undergo surgery and be assessed at multiple post-operative time points to determine the primary outcome of tympanic membrane closure. The gel is applied during surgery to support grafts and pack the ear canal.

Why it matters

Who can join: the full rules

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

Where it's running

• The Queen Elizabeth Hospital
  Adelaide, South Australia, Australia Recruiting
• The Memorial Hospital
  North Adelaide, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Prof Peter-John Wormald, MD — Central Adelaide Local Health Network
• Study coordinator: Prof Peter-John Wormald, MD,
• Email: pjwormald@gmail.com
• Phone: +61 8 82227158

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.