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Pre-treatment drops or spray for managing earwax

A comparison of the effectiveness of pre-treatment olive oil used as drops versus spray prior to earwax removal by microsuction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28211073
Enrollment
1742
Registered
2024-12-23
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Pre-treatment of wax in patients accessing a wax removal service Ear, Nose and Throat

Interventions

The research study is a two-arm cluster randomised control trial. The clusters refer to GP practices and the two arms refer to the pre-treatment of olive oil drops and olive oil spray. The pre-treatme

Sponsors

Betsi Cadwaladr University Health Board
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adults over 18 years of age 2. Able to give informed consent for microsuction 3. Presence of wax in one or both ears giving rise to symptoms or need that warrant removal

Exclusion criteria

Exclusion criteria: 1. Under 18 years of age 2. Active ear infection 3. Active dermatitis 4. Perforated or non-intact tympanic membrane 5. Foreign body present in ear canal 6. Any contraindication for microsuction or use of wax softeners – previous ear surgery including mastoid obliteration; grommets in situ

Design outcomes

Primary

MeasureTime frame
The success and effectiveness of wax removal will be measured by comparing the proportion of patients where wax removal is successful at the first attempt, not needing a further visit, with those who need another visit for a re-attempt at removal. This is determined by the Audiology Practitioner immediately after microsuction.

Secondary

MeasureTime frame
1. Self-reported needs and symptoms assessed immediately following wax removal. The wax removal pathway is a needs-based pathway and each patient being seen for wax removal is asked about their main need/symptom for accessing the service. These needs/symptoms are documented by the Audiology Practitioner. Following the wax removal, the Audiology Practitioner asks the patient to rate how much improvement there is in their reported need/symptom on a five-point scale (much better, slightly better, about the same, slightly worse, much worse). 2. Post-microsuction visualisation ratings for the two groups as rated on an analogue scale immediately after microsuction is complete, assessed using the ratings below: 0 No or very minimal earwax, complete visualisation of tympanic membrane 1 Minor amount of earwax with majority of tympanic membrane visible 2 Moderate amount of earwax with only part of the tympanic membrane visible 3 Fully occluding wax, no visualisation of tympanic membrane 3. Adverse events of microsuction recorded as per normal clinical practice, any that occur in clinic during or immediately after microsuction and any reported by patients up to 1 week after microsuction.

Countries

United Kingdom, Wales

Contacts

Public ContactLinor Jones
Linor.Ll.Jones@wales.nhs.uk+44 (0)3000843864

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026