Effect of Chitodex Gel in Tympanoplasty Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Adelaide Local Health Network Incorporated
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Gelfoam
DeviceGELFOAM 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
DeviceThe 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Gelfoam ArmActive comparator 1 intervention
Group B: Chitodex ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with tympanic membrane closure
tympanic membrane closure will be assessed via otoscopy (images will be captured via the otoscopic equipment)
Time frame
Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively2
rate of tympanic membrane closure
Time taken for tympanic membrane to close, assessed by otoscopy (images will be captured via the otoscopic equipment)
Time frame
Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operativelySecondary outcomes
1
Number of participants with improved hearing
An audiogram will be used for assessment of hearing. It measures hearing thresholds in decibels over a range of noise frequencies from 200Hz up to 8000Hz. It is always performed in a sound-proof room with over ear headphones
Time frame
Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively2
Number of participants with improved eardrum function
Eardrum function will be tested by Tympanometry, which tests how well the eardrum moves. The audiologist will put a small probe into the ear. A small device attached to the probe will push air into the ear. The output from the probe is translated to a graph called a tympanogram.
Time frame
Pre-operatively, and 3 months and 6 months post-operatively3
Ease of use of product compared to active comparator - surgeon feedback
Ease of use of product will be assessed via surgeon's feedback The ease of which to place the packing material within the anterior mesotympanum will be assessed, as well as the ease with which adequate graft positioning was obtained at the end of surgery. This will be done on a 7-point Likert scale with 1 been very difficult and 7 being very easy to use. After the surgeon has finished the surgery, the trial staff will collect this score from the surgeon within 24 hours of the surgery.
Time frame
Once, on day of surgery (within 6 hours post-operatively)4
Time taken to complete surgery
Start and finish times for all surgeries is clocked into the hospital peri-operative software by the nursing staff in real time. This is a routine part of modern peri-operative care. These records can be retrieved to establish the total operating time of each surgery.
Time frame
Once, for the duration of the operation (hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Central Adelaide Local Health Network Incorporated
Lead sponsor
University of Adelaide
Collaborator
Source ClinicalTrials.gov