Gluing Lacerations Utilizing Epinephrine

Lacerations Clinical Trial

— GLUE  

Official title:

Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlled Trial of Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202487
• Other study ID #: 6138378804
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: April 9, 2013
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Minor lacerations are a commonly treated injury in the paediatric emergency department . Over the past decade, standard closure of these lacerations has evolved from suture repair to closure with tissue adhesive (also referred to as "skin glue"). Local anaesthetic is not routinely used during application of skin glue as it was with sutures. There are, however, several potential advantages to pre-treating wounds with topical LET (Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive properties. Some believe LET can improve patient comfort, increase the ease of glue application, and lead to better healing when used on lacerations being repaired with tissue adhesive. This study aims to address the question of whether or not pre-treatment with LET improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual Analog Scale) during repair with tissue adhesive.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• aged 0 to 17 years inclusive;

• with a laceration that is less than 3 cm in length (the upper limit recommended for tissue adhesive repair by the manufacturer).

• with said laceration on the face, torso, trunk or extremities;

• with said laceration deemed by the treating physician to be appropriate for repair via tissue adhesive

Exclusion Criteria:

• the wound for study needs debridement or suturing prior to first glue attempt

• said wound is an animal or human bite or scratch wound, puncture wound, stellate crush wound, wound crossing mucocutaneous junctions, a scalp laceration, an ear laceration, a wound crossing a joint line, a wound on the fingers or toes, or a wound in an area of concentrated hair such as the eyebrow

• the patient has a history of keloid formation or

• a known allergy to cyanoacrylates or

• is presently taking oral steroids, immunostimulants, anticoagulants or other medications known to impair wound healing or haemostasis; or

• has a known diagnosis of Diabetes Mellitus or Vascular Insufficiency

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lacerations

Intervention

Drug:
• LET - Lidocaine Epinephrine Tetracaine
One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain of Procedure Rating	Patients will rate the pain experienced during their procedure on a 100 mm Visual Analog Scale (in paitents age 6 and under, parents will rate what pain they believe their child experienced).	2 minutes post-procedure	No
Secondary	Wound Cosmesis	Patients will return 3 months post laceration repair for a photograph on their wound. Plastic surgeons blinded to the treatment arm will rate the wound cosmesis via the photographs on a validated 100 mm Visual Analog Scale	measured at 3 month f/u visit	No
Secondary	Ease of procedure as measured by treating physician	Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale.	5 minutes post-procedure	No