A randomised study to compare temporalis fascia and thin cartilage slices in eardrum repair
| ISRCTN | ISRCTN65587606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65587606 |
| Protocol serial number | N0254119960 |
| Sponsor | Department of Health (UK) |
| Funders | Ipswich Hospital NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 01/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr MW Yung
Scientific
Scientific
The Ear Nose and Throat Department
Ipswich Hospital
Heath Road
Ipswich, Suffolk
IP4 5PD
United Kingdom
| Phone | +44 (0)1473 703 527 |
|---|---|
| matthew.yung@ipswichhospital.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Intact tympanic membrane |
| Key secondary outcome measure(s) |
Hearing levels and air-bone gaps |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Ear Nose and Throat Department
Ipswich, Suffolk
IP4 5PD
United Kingdom
IP4 5PD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
