Condition category
Ear, Nose and Throat
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21922978

Publication citations

  1. 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.

Additional files

Editorial Notes