A randomized trial comparing Octyl-cyanoacrylate and subcuticular sutures for post-auricular wound cosmesis

Not Applicable

Completed

• Conditions: Surgery: Ear; Surgery; Ear

• Registration Number: ISRCTN96030942
• Lead Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified