Gluing Lacerations Utilizing Epinephrine

Phase 2CompletedNCT01202487

Children's Hospital of Eastern Ontario222 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

222

Conditions

Lacerations

Interventions

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 2 minutes post-procedure

Secondary Outcomes

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

Time frame: 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.

Time frame: 5 minutes post-procedure