Repair of Symptomatic Ear Drum Perforations: A Pilot Study Using Celgro Trademark Type I/III Collagen Bioscaffold
Orthocell Ltd
15 participants
Feb 27, 2014
Interventional
Conditions
Summary
More than 106,000 Australians suffer from hearing loss and chronic ear infections related to perforations of the ear drum. Closure of these perforations traditionally requires surgery lasting up to an hour or more under general anaesthesia. Conventional myringoplasty has closure rates of ~85% in non-Indigenous populations and 50-70% in Indigenous populations. This project validates a new approach for closure of perforations requiring minimal surgery. Adults are treated under local anaesthesia with a Celgro Trademark Type I/III Collagen Bioscaffold mixed with fibrin glue placed into the perforation, thereby promoting the self-healing capacity of the eardrum.
Eligibility
Plain Language Summary
Simplified for easier understanding
This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Celgro Trademark Type I/III Collagen Bioscaffold. The Type I/III Collagen Bioscaffold is circumferentially grafted onto the tympanic membrane perforation edge. The procedure is expected to take approximately 15 minutes and it undertaken on a single occasion only. Participants receive a local anaesthetic for this procedure.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000532606