Comparing Chitodex Gel and Gelfoam in Ear Surgery
A Single-blinded Randomised Trial Evaluating the Efficacy of Chitosan-dextran (Chitodex) Gel Versus Gelfoam Sponge Instillation Within the Middle Ear and External Auditory Canal During Tympanoplasty Surgery
This study is testing whether a new gel called Chitodex works better than the usual packing material, Gelfoam, during ear surgeries to help patients heal and close their eardrum effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Adelaide Local Health Network Incorporated Government |
| Locations | 2 sites (Adelaide, South Australia and 1 other locations) |
| Trial ID | NCT06260618 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with tympanic membrane perforations requiring surgical closure, ossicular chain disruptions, or chronic otitis media.
Not a fit: Patients with cholesteatoma or those whose operative ear is their only hearing ear may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and faster recovery for patients undergoing ear surgeries.
How similar studies have performed: Other studies have shown promise in using alternative packing agents in ear surgeries, but the specific use of Chitodex gel is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Adelaide, South Australia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.