LacerationsPhase 2GLUENCT01202487
Gluing Lacerations Utilizing Epinephrine
A Phase 2 study testing LET - Lidocaine Epinephrine Tetracaine in people with Lacerations, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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"). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Lacerations
- What is being tested?
- LET - Lidocaine Epinephrine Tetracaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- LET - Lidocaine Epinephrine Tetracaine
- 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
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LET - Lidocaine Epinephrine TetracaineDrug
Also called LAT, Lidocaine Adrenaline Tetracaine
One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair
| Study group | Role | What they receive |
|---|---|---|
| Pre-treatment with LET | Experimental | Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive Receives: 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 Receives: Drug: LET - Lidocaine Epinephrine Tetracaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 minutes post-procedure
Secondary outcomes (2)
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
Measured: measured at 3 month f/u visit
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.
Measured: 5 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Harman, Children's Hospital of Eastern Ontario
- Investigators
- Stuart GS Harman, MD FRCPC, Principal investigator, Children's Hospital of Eastern OntarioRoger Zemek, MD FRCPC, Study director, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202487
- Sponsor's protocol ID
- 6138378804
- Acronym
- GLUE
- Status last verified
- Apr 2013
- First submitted
- 14 Sep 2010
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01202487
- Acronym / sponsor ID
- GLUE / 6138378804
- Conditions
- Lacerations
- Keywords
- Laceration, Lacerations, LET, Lidocaine Epinephrine Tetracaine, LAT, Lidocaine Adrenaline Tetracaine, Tissue Adhesive, Skin Glue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-treatment with LET | Experimental | Drug: LET - Lidocaine Epinephrine TetracainePre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive |
| Pre-treatment with Placebo | Placebo comparator | Drug: LET - Lidocaine Epinephrine TetracainePre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LET - Lidocaine Epinephrine TetracaineAlso: LAT, Lidocaine Adrenaline TetracaineOne time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair | Drug | Pre-treatment with LET, Pre-treatment with Placebo |
Primary outcome
Pain of Procedure Rating
Time frame: 2 minutes post-procedure
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 secondary outcomes
Wound Cosmesis
Time frame: measured at 3 month f/u visit
Ease of procedure as measured by treating physician
Time frame: 5 minutes post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart GS Harman, MD FRCPC principal investigator
Children's Hospital of Eastern Ontario
Roger Zemek, MD FRCPC study director
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LET - Lidocaine Epinephrine Tetracaine in people with Lacerations, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain of Procedure Rating (time frame: 2 minutes post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013; AzTrials last refreshed its copy on 28 Oct 2026.