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New treatment option for Tympanic Membrane Perforation
Official title Effect of Chitodex Gel in Tympanoplasty Surgery
ClinicalTrials.gov ID: NCT06260618
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram...
- The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND
- Are indicated to undergo closure of the perforation via tympanoplasty surgery
- OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae
- OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma
You likely can't join if
- Operative ear is the better or only hearing ear
- The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination
- dysfunction during otoscopic and tympanometric examination
- Known allergy to shellfish or ciprofloxacin antibiotics
- Pregnant or breastfeeding
- Hepatitis, HIV or any blood disorders
See the full eligibility criteria
- 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
- The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND
- Are indicated to undergo closure of the perforation via tympanoplasty surgery
- OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae
- OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma
- Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND
- Are 18 years of age or over AND
- Are able to give written informed consent AND
- Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op
- Operative ear is the better or only hearing ear
- The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination
- dysfunction during otoscopic and tympanometric examination
- Known allergy to shellfish or ciprofloxacin antibiotics
- Pregnant or breastfeeding
- Hepatitis, HIV or any blood disorders
- COVID-19 positive patients
- Contra-indications for MRI
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
- North Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia; North Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.