RecruitingPhase 2ACTRN12614000532606

Repair of Symptomatic Ear Drum Perforations: A Pilot Study Using Celgro Trademark Type I/III Collagen Bioscaffold


Sponsor

Orthocell Ltd

Enrollment

15 participants

Start Date

Feb 27, 2014

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new, less invasive way to close holes in the eardrum (called tympanic membrane perforations). Instead of traditional surgery under general anaesthesia, this approach uses a collagen scaffold and fibrin glue placed into the hole under local anaesthesia in a short procedure. Over 106,000 Australians have hearing loss or chronic ear infections related to these perforations. Researchers hope this new method can close the holes just as effectively with fewer risks. You may be eligible if: - You are 18 to 65 years old - You are an adult with a chronic (long-lasting) perforation of your eardrum You may NOT be eligible if: - You are under 18 years of age Talk to your doctor about whether this trial might be right for you.

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

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)

Fremantle Hospital and Health Service - Fremantle

WA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000532606