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?

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000371998

Enrollment

Registered

2011-04-11

Start date

2011-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

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 50 Years

Healthy volunteers

Yes

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.

Exclusion criteria

Known perforated ear drum. Infected ear.

Outcome results