Are topical antibiotics required for the treatment of otitis externa?
| ISRCTN | ISRCTN04939619 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04939619 |
| Protocol serial number | NRR Pub ID N0234117609 |
| Sponsor | North Bristol NHS Trust (UK) |
| Funder | Internal: Department of Otolaryngology, North Bristol NHS Trust (own account) (UK) |
- Submission date
- 23/09/2005
- Registration date
- 20/10/2006
- Last edited
- 29/01/2010
- 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 Desmond Nunez
Scientific
Scientific
Academic Dept. of Otolaryngology
North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That there is no difference between plain steroid drops or combination steroid and antibiotic drops in the resolution of otitis externa. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Otitis Externa |
| Intervention | Aural toilet and Vista Metasone topical drops versus Aural toilet and topical Vista Metasone-N over a 2 week period |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Plain steroid drops or combination steroid and antibiotic drops |
| Primary outcome measure(s) |
Subjects' visual analogue symptom scores for otitis externa pre and post treatment. |
| Key secondary outcome measure(s) |
Observer' s visual analogue scores for signs of otitis externa pre and post treatment. |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 55 |
| Key inclusion criteria | Patients with otitis externa presenting to the otolaryngology emergency clinic of an acute urban teaching hospital. |
| Key exclusion criteria | 1. Patients under the age of 18 years 2. Diabetics 3. Immunocompromise 4. Evidence of concurrent middle ear disease 5. Non-English speakers 6. Mental impairment 7. Allergy to the medicine 8. Previous treatment with the trial medication 9. Patients declining to participate |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Dept. of Otolaryngology
Bristol
BS10 5NB
United Kingdom
BS10 5NB
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 | 01/01/2009 | Yes | No |
