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Completed

NCT Number: NCT01202487

Gluing Lacerations Utilizing Epinephrine

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.

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Key information

Conditions

Lacerations Wounds and Injuries

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LET - Lidocaine Epinephrine Tetracaine

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Registry information

Official study 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

Acronym: GLUE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2010
Registry last updated
Apr 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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