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 healthy individuals. We hypothesis the ear gel will gelate in the ear canal causing minimal adverse events.
Interventions
This study will involve two stages:
Stage 1: 0.1ml of thermoresponsive gel will be placed onto the right upper back by the principle investigator/medical professional. The average time for the gel to set will be recorded and once set the wound will be covered with an adhesive dressing. The patient will be asked to keep this in place and as dry as possible for 48 hours. After 48 hours the participant will be reviewed and the dressing will be removed in clinics. The underlying skin will be revie
This study will involve two stages: Stage 1: 0.1ml of thermoresponsive gel will be placed onto the right upper back by the principle investigator/medical professional. The average time for the gel to set will be recorded and once set the wound will be covered with an adhesive dressing. The patient will be asked to keep this in place and as dry as possible for 48 hours. After 48 hours the participant will be reviewed and the dressing will be removed in clinics. The underlying skin will be reviewed for signs of reaction. The participants will be reviewed again 7 days post treatment. At this time a questionnaire will be completed and if no adverse reaction or events have occurred and the patient is happy to continue will begin stage 2 of treatment. Stage 2: - Patients will have pictures taken of there ear canal via a camera inserted into the outer ear canal. Following this they will receive a dose of 0.85ml of thermoresponsive ear gel via syringe and soft cannula to the left ear canal by the principle investigator/medical professional. Further photos will be taken following the thermoresponsive gel application and then at 2-4 hours and 6-8 hours after the gel was initially applied (Day 1). This will be repeated on day 2, 5, 8 and 12 or until the gel is no longer visible. If still present at day 12 - the gel will be removed using aqua ear solution to flush. Patients will be asked to complete a short questionnaire following completion of trial.
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
Yes
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 Patients with infection or irritation of the ear canal 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 Patients who have had their ear canal treated with topical antibiotics, steroids or antifungal within 7 days of presentation o Use of topical alcohol, vinegar, hydrogen peroxide or other medication to the affected ear leading up to the visit 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