Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000371998
Ethics application status
Not yet submitted
Date submitted
3/04/2011
Date registered
11/04/2011
Date last updated
11/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Can the placement of ear canal wick (medical sponge) prevent the flow of antibiotic ear drops into the middle ear space (where it can cause side-effects) in patients with known or suspected perforation in their ear drum?
Scientific title
In patients presenting with otitis externa, can the use of Pope ear wicks reduce the chance of ototoxic antibiotic ear drops entering the ear canal and therefore reduce the chance of developing sensorineural hearing loss
Secondary ID [1] 259897 0
Nil
Universal Trial Number (UTN)
U1111-1120-4723
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis externa 265509 0
Condition category
Condition code
Ear 265660 265660 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Otowick is a self-expanding medical sponge that is placed in the ear canal. Otowick expands when ear drops are instilled to fill up the ear canal, assisting administration of ear drops deep into the ear canal in the treatment of such ear condtions as otitis externa (swimmer's ear). Typically otitis externa is treated with aminoglycoside/steroid combination ear drops (e.g. Sofradex, Otodex, Kenacomb Otic at 3 drops 3 times daily). However due to potential oto-toxicity which may result in hearing loss, aminoglycoside antibiotic drops are contraindicated in ear canals with known or suspected ear drum perforation. This trial will mirror a routine local ear treatment whereby participants will receive these routine ear drops at routine dosing (3 drops 3 times a day) but the drops will have Fluorescein dye to identify their behaviour in the ear canal when ear wick is placed. The trial will run for 1 day i.e. drops given t.d.s. and ear inspected the following day.
Intervention code [1] 264329 0
Treatment: Devices
Intervention code [2] 264372 0
Treatment: Drugs
Comparator / control treatment
N/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262443 0
Staining of ear drum with fluorescein or absence of staining
Timepoint [1] 262443 0
24 hours post instillation of fluorescein stained ear drops
Secondary outcome [1] 273790 0
Nil
Timepoint [1] 273790 0
Not applicable

Eligibility
Key inclusion criteria
Because we are testing whether placement of otowick will ensure routine aminoglycoside ear drops can be used when ear drums are perforated (by holding onto the drop and preventing the drops from flowing past perforated ear drum into the ear canal) thus enabling safe use in known or suspected cases of ear drum perforation, we aim to study this in a healthy normal ears to ascertain the relationship between wick and ear drop flow within the ear.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known perforated ear drum. Infected ear.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting healthy individuals (total of 8 partcipants) who meet inclusion crietria
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation required
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
In vivo trial of using otowick to prevent instillation of ear drops into middle ear
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264792 0
Hospital
Name [1] 264792 0
The Royal Victorian Eye and Ear Hospital
Country [1] 264792 0
Australia
Primary sponsor type
Hospital
Name
The Royal Victorian Eye and Ear Hospital
Address
32 Gisborne St, East Melbourne, Victoria 3002
Country
Australia
Secondary sponsor category [1] 263904 0
None
Name [1] 263904 0
Address [1] 263904 0
Country [1] 263904 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266764 0
Ethics committee address [1] 266764 0
Ethics committee country [1] 266764 0
Date submitted for ethics approval [1] 266764 0
14/04/2011
Approval date [1] 266764 0
Ethics approval number [1] 266764 0

Summary
Brief summary
Otitis externa causes swelling of the ear canal which makes visualisation of ear drum very difficult or often impossible. Primary care physicians regularly use ear drop known as Ciloxan or Ciproxin HC to treat otitis externa when ear drums are not visualised as these drops are indicated in the presence of actual or suspected ear drum perfortion. More broad spectrum, cheaper alternatives such as Sofradex, Otodex, Kenacomb/Otocomb Otic drops are not regularly used for the fear of introducing these to the middle ear space where these drugs can potentially be ototoxic. We, however, believe that by placing an otowick (self-expanding sponge) in the ear canal and then using these drops, they can be safely delivered to the external ear without risking the potential entry of these drops into the middle ear in presence of a perforated ear drum. By staining these drops with fluorescein, we will know if standard instillation (3 drops 3 times a day) of these drops will be limiting the drug presence within the external ear canal only when an otowick is placed in the ear canal by looking at whether staining of the ear drum occurs. If ear drums are stainined then we can assume that drugs can reach middle ear if ear drum is perforated even if there is a otowick in place.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32423 0
Address 32423 0
Country 32423 0
Phone 32423 0
Fax 32423 0
Email 32423 0
Contact person for public queries
Name 15670 0
Philip Michael
Address 15670 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St, East Melbourne, Victoria
3002
Country 15670 0
Australia
Phone 15670 0
+61 3 99298666
Fax 15670 0
Email 15670 0
[email protected]
Contact person for scientific queries
Name 6598 0
Philip Michael
Address 6598 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St, East Melbourne, Victoria
3002
Country 6598 0
Australia
Phone 6598 0
+61 3 99298666
Fax 6598 0
Email 6598 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.