None listed
Conditions
Brief summary
Otitis Externa (swimmers ear) is inflammation of the ear canal and leads to significant pain. The current treatment involves ear drops which are difficult to insert and requiring regular insertion. This leads to decreased patient compliance and a notably increasing level of antimicrobial resistance. This project involves the initial assessment of a newly created thermoresponsive ear gel (a gel that is drops at room temperature and changes to a gel a body temperature) in individuals with otitis externa. We hypothesis the ear gel will gelate in the ear canal, treating otitis externa and causing minimal adverse events.
Interventions
The patient will receive a single dose of 0.5ml of the thermoresponsive gel containing active ingredients ciprofloxacin 0.6% and dexamethasone 0.2%. This will be delivered by blunt needle and syringe to the ear canal. Patient review/follow up will occur on day 2, if no improvement is seen patients will be removed from the study and given alternative treatment. Further review will occur on day 5 and 12 review of patient symptoms, side effects and ear will occur to ensure patient safety. If the ge
The patient will receive a single dose of 0.5ml of the thermoresponsive gel containing active ingredients ciprofloxacin 0.6% and dexamethasone 0.2%. This will be delivered by blunt needle and syringe to the ear canal. Patient review/follow up will occur on day 2, if no improvement is seen patients will be removed from the study and given alternative treatment. Further review will occur on day 5 and 12 review of patient symptoms, side effects and ear will occur to ensure patient safety. If the gel remains visible in the external auditory canal at day 12 review, aural toilet will be performed to remove any of the remaining gel. Patients will be contacted four weeks following cessation of treatment to ensure no recurrence or side effects have occurred.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
o Aged between 18-60 years at time of recruitment o ASA 1-28 (healthy, non-smoker or with mild disease without substantive functional limitations) o Available for ongoing follow up and review
Exclusion criteria
o Overt fungal otitis externa based on clinical examination o Congenital abnormality, obstructive exostoses or malignancy of the ear canal o Seborrheic dermatitis or other dermatological conditions of the affected external ear canal. o Known or suspected tympanic membrane perforation or tympanostomy tube o Known allergy or sensitivity to ciprofloxacin, quinolones, dexamethasone, corticosteroids or shell fish. o Patients who have an ASA 3 or more (severe systemic disease)8 o Patients who are pregnant or lactating
Outcome results
None listed