Actively Recruiting
A Single-blinded Randomised Trial Comparing Chitosan-dextran Gel and Gelfoam Sponge as Middle Ear and External Auditory Canal Packing During Tympanoplasty Surgery
Led by Central Adelaide Local Health Network Incorporated · Updated on 2024-11-13
44
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Central Adelaide Local Health Network Incorporated
Lead Sponsor
U
University of Adelaide
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the use of Chitosan-dextran (Chitodex) gel with the current standard treatment, Gelfoam, as packing materials for the middle ear and external auditory canal during tympanoplasty, ossiculoplasty, and mastoidectomy surgeries. It focuses on patients with tympanic membrane perforations, ossicular chain damage, or chronic otitis media and seeks to identify which material better supports healing and reduces inflammation. The study is a single-blinded, randomized trial assessing surgical success and healing outcomes. During surgery, Chitodex gel is applied in a similar manner to Gelfoam. Approximately 2 mL of gel or foam is placed inside the middle ear to support the graft, followed by about 3 mL applied to the external auditory canal as packing. Both materials come in sterile packaging, and surgeons administer the product during the procedure. The study measures the effectiveness of each product in sealing the graft and preventing air leakage, with images and notes taken for evaluation. Participants will be monitored at several points after surgery: 2 and 6 weeks, then 3 and 6 months post-operation. Researchers will check tympanic membrane closure using otoscopic or microscope examination. Additional assessments include hearing improvement, eardrum function, quality of life, surgical ease, operation duration, and the clearance of Chitodex gel from the ear. These evaluations will help determine which packing agent is preferable for middle ear surgery.
CONDITIONS
Brief Title
Effect of Chitodex Gel in Tympanoplasty Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a confirmed tympanic membrane perforation shown by otoscopy and tympanometry
- Tympanic membrane perforation with at least 15dB conductive hearing loss on the affected side
- Indicated for closure of perforation via tympanoplasty surgery or indicated for ossiculoplasty due to ossicular disruption or mastoidectomy for chronic otitis media or sequelae
- Have healthy, dry middle ear mucosal cavities at time of surgery
- Are 18 years of age or older
- Able to provide written informed consent
- Committed to returning for postoperative assessments at 2 and 6 weeks, 3 months, and 6 months post-op
You will not qualify if you...
- Operative ear is the better or only hearing ear
- Presence of cholesteatoma or other middle ear tumors during examination
- Dysfunction detected during otoscopic and tympanometric examinations
- Known allergy to shellfish or ciprofloxacin antibiotics
- Pregnant or breastfeeding
- Have hepatitis, HIV, or any blood disorders
- Tested positive for COVID-19
- Contraindications for MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo screening visits to confirm tympanic membrane perforation, hearing loss, and middle ear health.
Duration - Day of surgery
Participants undergo tympanoplasty surgery during which either Chitodex gel or Gelfoam is applied as middle ear and external auditory canal packing to support graft placement and closure of the tympanic membrane perforation.
1 visit (in-person) for the surgery and immediate post-operative care
Duration - 6 months
Participants attend follow-up visits to assess tympanic membrane closure, hearing improvement, and graft positioning using otoscopy and imaging at multiple time points after surgery.
4 visits (in-person) at approximately 2 weeks, 6 weeks, 3 months, and 6 months post-surgery
Trial Site Locations
Total: 2 locations
1
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Actively Recruiting
2
The Memorial Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
Research Team
P
Prof Peter-John Wormald, MD,
E
Emma Barry, BSc (Hons)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here