Gluing Lacerations Utilizing Epinephrine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lacerations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pre-treatment with LET

Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive

Group Type EXPERIMENTAL

LET - Lidocaine Epinephrine Tetracaine

Intervention Type DRUG

One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair

Pre-treatment with Placebo

Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive

Group Type PLACEBO_COMPARATOR

LET - Lidocaine Epinephrine Tetracaine

Intervention Type DRUG

One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair

Interventions

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LET - Lidocaine Epinephrine Tetracaine

One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair

Intervention Type DRUG

Other Intervention Names

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LAT Lidocaine Adrenaline Tetracaine

Eligibility Criteria

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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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No