A randomised study to compare temporalis fascia and thin cartilage slices in eardrum repair

ISRCTN	ISRCTN65587606
DOI	https://doi.org/10.1186/ISRCTN65587606
Secondary identifying numbers	N0254119960

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr MW Yung
Scientific

The Ear Nose and Throat Department
Ipswich Hospital
Heath Road
Ipswich, Suffolk
IP4 5PD
United Kingdom

Phone	+44 (0)1473 703 527
Email	matthew.yung@ipswichhospital.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title
Study objectives	Is there a difference in the efficacy and safety of the two most popular eardrum grafting materials, temporalis fascia and thin cartilage slices?
Ethics approval(s)	Ethics approval was received from the local medical ethics committee in 2002 before trial recruitment began.
Health condition(s) or problem(s) studied	Ear, Nose and Throat: Eardrum repair
Intervention	Comparing temporalis fascia and thin cartilage slices.
Intervention type	Other
Primary outcome measure	Intact tympanic membrane
Secondary outcome measures	Hearing levels and air-bone gaps
Overall study start date	09/01/2003
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 patients
Key inclusion criteria	Patients with a larger eardrum perforation who require a surgical repair.
Key exclusion criteria	1. Perforations less than 75% size of the eardrum 2. Any patient who has a concomitant ossicular chain damage or fixation 3. Patients who do not have sufficient understanding of the information given to offer consent
Date of first enrolment	09/01/2003
Date of final enrolment	31/12/2008

The Ear Nose and Throat Department

Ipswich, Suffolk
IP4 5PD
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

Ipswich Hospital NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No