Gluing Lacerations Utilizing Epinephrine (GLUE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stuart Harman, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01202487
First received: September 14, 2010
Last updated: April 9, 2013
Last verified: April 2013

September 14, 2010
April 9, 2013
April 2011
January 2012   (final data collection date for primary outcome measure)
Pain of Procedure Rating [ Time Frame: 2 minutes post-procedure ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01202487 on ClinicalTrials.gov Archive Site
  • Wound Cosmesis [ Time Frame: measured at 3 month f/u visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 minutes post-procedure ] [ Designated as safety issue: No ]
    Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale.
Same as current
Not Provided
Not Provided
 
Gluing Lacerations Utilizing Epinephrine
Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlled Trial of Efficacy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Lacerations
Drug: LET - Lidocaine Epinephrine Tetracaine
One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair
Other Names:
  • LAT
  • Lidocaine Adrenaline Tetracaine
  • Experimental: Pre-treatment with LET
    Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive
    Intervention: Drug: LET - Lidocaine Epinephrine Tetracaine
  • Placebo Comparator: Pre-treatment with Placebo
    Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive
    Intervention: Drug: LET - Lidocaine Epinephrine Tetracaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
April 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01202487
6138378804
Yes
Stuart Harman, Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
Not Provided
Principal Investigator: Stuart GS Harman, MD FRCPC Children's Hospital of Eastern Ontario
Study Director: Roger Zemek, MD FRCPC Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP