The effectiveness of Otinova for AOE in primary and secondary care.
Research type
Research Study
Full title
The effectiveness of Otinova (Burow’s solution) for mild-moderate Acute Otitis Externa in primary and secondary care: A feasibility study
IRAS ID
318799
Contact name
Matthew Smith
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Clinicaltrials.gov Identifier
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Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The aim of this study is to understand how well a new non-antibiotic spray works as a treatment for acute otitis externa (outer ear infection). By using a non-antibiotic we may be able to reduce antibiotic resistance, which is one of the biggest issues facing healthcare. We do not know if the spray is equally effective, more effective, or less effective than antibiotic drops or spray. If the new treatment is eventually proven to be effective this could become the usual treatment for acute otitis external.
We are testing Otinova spray, a medicine similar to Burrow’s Solution which has been used to treat ear infections in the UK for over 50 years. Otinova spray contains aluminium salts and a pure form of vinegar (acetic acid). Published studies and our own recent work analysing these suggests that non-antibiotic treatments such as Otinova may be as effective as antibiotic treatments for acute otitis externa.
Patients with acute otitis externa will be offered Otinova spray in place of standard care (antibiotic spray or drops) when they are seen at a hospital or GP ENT clinic. Participation will be optional, and it will not affect the way that they are followed up in clinic. Consenting participants will answer a questionnaire about their condition's symptoms, and a clinician will enter information about the appearance of their ear. All study records will be anonymised. As with most acute otitis externa patients, participants will be seen 7 and then 14 days after their treatment starts. At this point participants will again answer a questionnaire, and have their ears examined. If the otitis externa is worsening at 7 days or has not resolved at 14 days, antibiotics will be started. We will compare results from the Otinova spray with other patients we have previously treated with antibiotics.
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0156
Date of REC Opinion
31 May 2024
REC opinion
Favourable Opinion