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Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair (LET Trial)

Phase 4
Waitlist Available
Led By Joshua Siembieda
Research Sponsored by Children's Hospital of Orange County
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* • Patients with simple (\< 3 cm) lacerations who are \> 7 years old and \< 18 years old, for whom the physician plans to close the laceration using simple superficial interrupted sutures.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the parental satisfaction likert scale will be collected immediately after the procedure.
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET). Single LET is the current standard method of application.

Eligible Conditions
  • Skin Lacerations
  • Tay-Sachs Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the provider satisfaction likert scale will be collected immediately after the procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the provider satisfaction likert scale will be collected immediately after the procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To compare pain scores
Secondary study objectives
To compare parental satisfaction scores
To compare provider satisfaction scores

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: 1 applicationActive Control1 Intervention
Patients receive single dose LET
Group II: 3 applicationsActive Control1 Intervention
Patients receive 3 doses of LET

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Who is running the clinical trial?

Children's Hospital of Orange CountyLead Sponsor
34 Previous Clinical Trials
5,229 Total Patients Enrolled
Joshua SiembiedaPrincipal InvestigatorCHOC Childrens
~7 spots leftby Dec 2025
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