Gluing Lacerations Utilizing Epinephrine
- Conditions
- Lacerations
- Interventions
- Drug: LET - Lidocaine Epinephrine Tetracaine
- Registration Number
- NCT01202487
- Lead Sponsor
- Children's Hospital of Eastern Ontario
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pre-treatment with LET LET - Lidocaine Epinephrine Tetracaine Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive Pre-treatment with Placebo LET - Lidocaine Epinephrine Tetracaine Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada