A non-inferiority study of the clinical effectiveness of anaesthesia obtained via application of Topical Anaesthetic Gel compared to infiltration of lidocaine for the treatment of lacerations in the Emergency Department

orthern Health and Social Care Trust0 sites110 target enrollmentApril 16, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Small to medium sized lacerations with no underlying nerve or other gross structural damage which would require further medical or surgical investigation.
Sponsor: orthern Health and Social Care Trust
Enrollment: 110
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

April 16, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

orthern Health and Social Care Trust

•Adult patients (18 years of age or older) who attend the Emergency Department at Antrim Hospital for treatment of a laceration.
•Potential participants must have a laceration that requires sutures.
•Patients must provide written informed consent to participate.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•Patients who attend with wounds that can be approximated by tissue adhesives or steristrips.
•Patients who attend with animal or human bites or wounds which show gross contamination.
•Patients with puncture or crush wounds and scalp lacerations will also be excluded. Wounds occurring across joints and lacerations of tendon, nerve or cartilage.
•Patients with systemic disease including; collagen vascular disease, immunodeficiency, HIV, skin disorders, diabetes mellitus or bleeding disorders.
•Patients taking warfarin or drugs that cause methaemoglobinaemia.
•Patients who are allergic to either lidocaine or any of the other formulation ingredients.