Effect of Chitodex gel in ear drum repair (tympanoplasty) surgery

Not Applicable

Recruiting

• Conditions: tympanic membrane perforation; ear drum repair surgery; tympanoplasty surgery; Mastoid surgery; Ear - Other ear disorders; Surgery - Other surgery

• Registration Number: ACTRN12621001058864
• Lead Sponsor: Central Adelaide Local Health Network (CALHN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-11
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Participants who meet ALL of the following criteria will be considered for inclusion:
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
2.The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND
3.Are indicated to undergo closure of the perforation via tympanoplasty surgery
4.OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and it’s sequelae
5. OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma
6.Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND
7.Are 18 years of age or over AND
8.Are able to give written informed consent AND
9.Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op, and an MRI 4 weeks post-op

Exclusion Criteria

1.Operative ear is the better or only hearing ear
2.dysfunction during otoscopic and tympanometric examination
3.Known allergy to shellfish or ciprofloxacin antibiotics
4.Pregnant or breastfeeding
5.Hepatitis, HIV or any blood disorders
6.COVID-19 positive patients
7.Contra indications for MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tympanic membrane closure assessed via otoscopy (images will be captured via the otoscopic equipment)[ 2 weeks post-operatively<br>6 weeks post-operatively<br>3 months post-operatively (primary timepoint)<br>6 months post-operatively]