Are topical antibiotics required for the treatment of otitis externa?
| ISRCTN | ISRCTN04939619 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04939619 |
| Secondary identifying numbers | NRR Pub ID N0234117609 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Plain steroid drops or combination steroid and antibiotic drops |
| Primary outcome measure | Subjects' visual analogue symptom scores for otitis externa pre and post treatment. |
| Secondary outcome measures | Observer' s visual analogue scores for signs of otitis externa pre and post treatment. |
| Overall study start date | 01/06/2003 |
| Overall study end date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 55 |
| Participant inclusion criteria | Patients with otitis externa presenting to the otolaryngology emergency clinic of an acute urban teaching hospital. |
| Participant 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 |
| Recruitment start date | 01/06/2003 |
| Recruitment end date | 01/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Dept. of Otolaryngology
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
North Bristol NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Support Unit
Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom
"ROR" |
https://ror.org/036x6gt55 |
|---|
Funders
Funder type
Government
Internal: Department of Otolaryngology, North Bristol NHS Trust (own account) (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
