Gluing Lacerations Utilizing Epinephrine (GLUE)

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

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.

Study Overview

• Status: Completed
• Conditions: Lacerations
• Intervention / Treatment: Drug: LET - Lidocaine Epinephrine Tetracaine

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-treatment with LET; Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive	Drug: LET - Lidocaine Epinephrine Tetracaine; One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair; Other Names: LAT; Lidocaine Adrenaline Tetracaine
Placebo Comparator: Pre-treatment with Placebo; Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive	Drug: LET - Lidocaine Epinephrine Tetracaine; One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair; Other Names: LAT; Lidocaine Adrenaline Tetracaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Investigators: Principal Investigator: Stuart GS Harman, MD FRCPC, Children's Hospital of Eastern Ontario; Study Director: Roger Zemek, MD FRCPC, Children's Hospital of Eastern Ontario

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 10, 2013
• Last Update Submitted That Met QC Criteria: April 9, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Tissue Adhesive; Laceration; Lacerations; LET; Lidocaine Epinephrine Tetracaine; LAT; Lidocaine Adrenaline Tetracaine; Skin Glue; Pre-Treatment with LET; Pre-Treatment with LAT; Pre-Treatment with Lidocaine Epinephrine Tetracaine; Pre-Treatment with Lidocaine Adrenaline Tetracaine; Use of LET with Skin Glue; Use of LET with Tissue Adhesive; Histoacryl
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Tetracaine
• Other Study ID Numbers: 6138378804