Contact information
Type
Scientific
Primary contact
Mr MW Yung
ORCID ID
Contact details
The Ear Nose and Throat Department
Ipswich Hospital
Heath Road
Ipswich
Suffolk
IP4 5PD
United Kingdom
+44 (0)1473 703 527
matthew.yung@ipswichhospital.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0254119960
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval was received from the local medical ethics committee in 2002 before trial recruitment began.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Ear, Nose and Throat: Eardrum repair
Intervention
Comparing temporalis fascia and thin cartilage slices.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Intact tympanic membrane
Secondary outcome measures
Hearing levels and air-bone gaps
Overall trial start date
09/01/2003
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with a larger eardrum perforation who require a surgical repair.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients
Participant 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
Recruitment start date
09/01/2003
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Ear Nose and Throat Department
Ipswich, Suffolk
IP4 5PD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ipswich Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21922978
Publication citations
-
Results
Yung M, Vivekanandan S, Smith P, Randomized study comparing fascia and cartilage grafts in myringoplasty., Ann. Otol. Rhinol. Laryngol., 2011, 120, 8, 535-541.