Gluing Lacerations Utilizing Epinephrine (GLUE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stuart Harman, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01202487
First received: September 14, 2010
Last updated: April 9, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Pain of Procedure Rating [ Time Frame: 2 minutes post-procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 14, 2010
Last Updated: April 9, 2013
Health Authority: Canada: Health Canada

Keywords provided by 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
Epinephrine
Epinephryl borate
Lidocaine
Racepinephrine
Tetracaine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014