Lacerations
Conditions
Keywords
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
Brief summary
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.
Interventions
DRUGLET - Lidocaine Epinephrine Tetracaine
One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair
Sponsors
Children's Hospital of Eastern Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain of Procedure Rating | 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
| Measure | Time frame | Description |
|---|---|---|
| Wound Cosmesis | 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 | 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. |
Countries
Canada
Outcome results
None listed