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Gluing Lacerations Utilizing Epinephrine (GLUE)

C

Children's Hospital of Eastern Ontario

Status and phase

Completed
Phase 2

Conditions

Lacerations

Treatments

Drug: LET - Lidocaine Epinephrine Tetracaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01202487
6138378804

Details and patient eligibility

About

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.

Enrollment

222 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

222 participants in 2 patient groups, including a placebo group

Pre-treatment with LET
Experimental group
Description:
Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive
Treatment:
Drug: LET - Lidocaine Epinephrine Tetracaine
Pre-treatment with Placebo
Placebo Comparator group
Description:
Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive
Treatment:
Drug: LET - Lidocaine Epinephrine Tetracaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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