Surgery: Ear Surgery Ear
Conditions
Interventions
Patients will be given the Patient Information Leaflet and informed consent will be obtained on enrolment, this will take place at the time of being listed for surgery. Demographic details will be lis
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This sample aims to have 80% power to detect a statistically significant difference between groups with 95% confidence if the true difference between treatment outcomes is at least 0.5 of a standardised difference (ie approximately 8mm on the visual analogue scale). This will require 125 patients in the final analysis. We aim to recruit 140 patients to allow for 10% loss to follow-up. Support was provided by Dr Bellamy in calculating the sample size. Inclusion criteria will be adult and paediatric patients undergoing ear surgery using a post-auricular incision.
Exclusion criteria
Exclusion criteria: Revision surgery, acute mastoiditis, diabetes mellitus, coagulopathy, personal or family history of keloid or hypertrophic scar formation, reopening of the wound eg for drainage of wound haematoma, allergy to skin glue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cosmetic appearance of post-auricular wounds as judged by a visual analogue scale assessment of photographs by assessors blinded to treatment allocation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time taken for skin closure (seconds) 2. Early wound complication (infection, dehiscence) assessed at 3 weeks 3. Cosmetic appearance of post-auricular wounds as judged by the Hollander Wound Evaluation Scale assessed at 3 months | — |
Countries
United Kingdom
Outcome results
None listed