CompletedPhase 2

Gluing Lacerations Utilizing Epinephrine

Canada222 participantsStarted 2011-04

Plain-language 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.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared using glue with epinephrine to close lacerations — how does that approach differ from the stitches or staples my doctor might normally use for my specific wound?
2Since this was a Phase 2 trial focused on measuring how painful the procedure is, does that mean there's still limited data on how well wounds actually heal long-term, and should that affect my treatment choice?
3The trial is now completed — has my doctor seen the results, and do those findings change what they'd recommend for closing my laceration?
4If the glue-with-epinephrine method wasn't available or wasn't right for me, what would the standard pain-management approach be during a typical laceration repair?
5Are there characteristics of my particular laceration — like its size, location, or depth — that would make me a good or poor candidate for the kind of tissue adhesive approach studied in this trial?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain of Procedure Rating

Timeframe: 2 minutes post-procedure

Trial details

NCT IDNCT01202487

SponsorChildren's Hospital of Eastern Ontario

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

View on ClinicalTrials.gov More Lacerations trials