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Gluing Lacerations Utilizing Epinephrine (GLUE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202487
First Posted: September 16, 2010
Last Update Posted: April 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stuart Harman, Children's Hospital of Eastern Ontario
  Purpose
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.

Condition Intervention Phase
Lacerations Drug: LET - Lidocaine Epinephrine Tetracaine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Stuart Harman, Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Pain of Procedure Rating [ Time Frame: 2 minutes post-procedure ]
    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).


Secondary Outcome Measures:
  • Wound Cosmesis [ Time Frame: measured at 3 month f/u visit ]
    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

  • Ease of procedure as measured by treating physician [ Time Frame: 5 minutes post-procedure ]
    Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale.


Enrollment: 222
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202487


Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
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
  More Information

Responsible Party: Stuart Harman, Dr. Stuart Harman MD FRCPC, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01202487     History of Changes
Other Study ID Numbers: 6138378804
First Submitted: September 14, 2010
First Posted: September 16, 2010
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Stuart Harman, Children's Hospital of Eastern Ontario:
Laceration
Lacerations
LET
Lidocaine Epinephrine Tetracaine
LAT
Lidocaine Adrenaline Tetracaine
Tissue Adhesive
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:
Lacerations
Wounds and Injuries
Lidocaine
Tetracaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents