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

Record Provided by the NHSTCT Register - 2007 Update - Department of Health0 sites140 target enrollmentSeptember 28, 2007

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Enrollment: 140
Status: Completed
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

September 28, 2007

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Sponsor

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

•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.

•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.