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Gluing Lacerations Utilizing Epinephrine (GLUE)

Primary Purpose

Lacerations

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
LET - Lidocaine Epinephrine Tetracaine
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacerations focused on measuring 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

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pre-treatment with LET

Pre-treatment with Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain of Procedure Rating
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

Wound Cosmesis
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
Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale.

Full Information

First Posted
September 14, 2010
Last Updated
April 9, 2013
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT01202487
Brief Title
Gluing Lacerations Utilizing Epinephrine
Acronym
GLUE
Official Title
Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlled Trial of Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacerations
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-treatment with LET
Arm Type
Experimental
Arm Description
Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive
Arm Title
Pre-treatment with Placebo
Arm Type
Placebo Comparator
Arm Description
Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive
Intervention Type
Drug
Intervention Name(s)
LET - Lidocaine Epinephrine Tetracaine
Other Intervention Name(s)
LAT, Lidocaine Adrenaline Tetracaine
Intervention Description
One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair
Primary Outcome Measure Information:
Title
Pain of Procedure Rating
Description
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).
Time Frame
2 minutes post-procedure
Secondary Outcome Measure Information:
Title
Wound Cosmesis
Description
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
Time Frame
measured at 3 month f/u visit
Title
Ease of procedure as measured by treating physician
Description
Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale.
Time Frame
5 minutes post-procedure

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart GS Harman, MD FRCPC
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roger Zemek, MD FRCPC
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

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Gluing Lacerations Utilizing Epinephrine

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