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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000532606

Enrollment

Registered

2014-05-20

Start date

2014-02-27

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Adult patients with chronic tympanic membrane perforations

Exclusion criteria

< 18 years

Outcome results