Gluing Lacerations Utilizing Epinephrine

NCT01202487 | Completed Phase 2 DMC

• 1 other identifier: 6138378804
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  2 minutes post-procedure

Secondary Outcomes (2)

• Wound Cosmesis

  measured at 3 month f/u visit

• Ease of procedure as measured by treating physician

  5 minutes post-procedure

Study Arms (2)

Pre-treatment with LET

EXPERIMENTAL

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

Drug: LET - Lidocaine Epinephrine Tetracaine

Pre-treatment with Placebo

PLACEBO COMPARATOR

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

Drug: LET - Lidocaine Epinephrine Tetracaine

Interventions

LET - Lidocaine Epinephrine Tetracaine DRUG

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

Also known as: LAT, Lidocaine Adrenaline Tetracaine

Pre-treatment with LET; Pre-treatment with Placebo

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Stuart GS Harman, MD FRCPC

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

• Roger Zemek, MD FRCPC

  Children's Hospital of Eastern Ontario

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Stuart Harman MD FRCPC

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: April 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

CA (1)