Tympanic Membrane PerforationTympanic Membrane InflammationSurgeryOtitis Media
Investigational drug(s) / intervention(s)
GelfoamChitodex
Gelfoam: GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine skin, Gelatin USP Granules and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids.
Chitodex: The Chitogel Endoscopic Sinus Surgery Kit contains components and equipment for the preparation of a nasal gel to be applied to the sinus cavities via a supplied and specifically designed malleable cannula.
The Gel preparation will take approximately 30 minutes, so preparation must start sufficiently in advance of when the Gel is expected to be used in surgery.
Once the Gel has been prepared it should be applied to the sinus cavities on both sides within six hours using the malleable cannula supplied with the Kit.
The Gel must be prepared on a sterile surface following these instructions. There are two main components to the Gel.
1. Dextran Aldehyde (B), which is a dry powder, and is reconstituted into a liquid form through mixing the powder with a liquid Sodium Phosphate Buffer (A). Both of these components are supplied sterile.
2. The second component Chitosan Succinamide (C), is a liquid and is also supplied sterile.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with tympanic membrane closure — Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively tympanic membrane closure will be assessed via otoscopy (images will be captured via the otoscopic equipment)
rate of tympanic membrane closure — Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively Time taken for tympanic membrane to close, assessed by otoscopy (images will be captured via the otoscopic equipment)
Trial sites (2)
Facility
City
Region
Status
The Queen Elizabeth Hospital
Adelaide
South Australia
Recruiting
The Memorial Hospital
North Adelaide
South Australia
Recruiting
More Central Adelaide Local Health Network Incorporated trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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