Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream

Last updated: June 5, 2023
Sponsor: Juerg Hafner
Overall Status: Active - Recruiting

Phase

2

Condition

Ulcers

Venous Leg Ulcers

Treatment

IMP2 (lidocaine-23%-tetracaine-7% gel)

IMP1 (EMLA 5% cream)

Clinical Study ID

NCT05890703
LIDOTETRA
  • Ages 18-90
  • All Genders

Study Summary

In a single-blind, crossover, randomized, controlled trial with 40 participants we aim to demonstrate superior anaesthetic efficacy of lidocaine-23%-tetracaine-7% (IMP2) gel over EMLA 5% cream (IMP1) at comparable safety in sharp wound debridement of chronic leg ulcers.

This is a monocentric investigator initiated trial conducted in the University Hospital Zurich.

In this longitudinal trial, participants receive a sequence of different treatments (treatments on different days) and therefore are randomly assigned to one of two treatment sequences. One-half of participants will first receive IMP1 (first treatment visit, randomized) and then IMP2 (second treatment visit, crossover); the other half of participants the reverse sequence (first treatment visit: IMP2, second treatment visit: IMP1).

Primary Objective: We want to show that IMP 2 (lidocaine-23%-tetracaine-7% gel) is more effective in pain reduction than IMP 1 (EMLA® 5% cream) in sharp wound debridement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants between 18 years and 90 years
  • Chronic leg ulcer(s) (duration > 4 weeks) with biofilm or necrotic layers whichrequire consecutive sharp debridement for at least two times (of the same ulcer)
  • Minimal ulcer area of 1 cm2
  • Leg ulcer has to enter into one of the following well defined aetiologies: venous,mixed venous-arterial, arterial, hypertensive ischemic leg ulcer (Martorell),vasculitic, ecthyma (covering >90% of all observed leg ulcers)
  • Informed consent as documented by signature and being able to follow the studyprotocol (cognition)
  • Proficiency in German, oral and written information

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding (Women of childbearing potential need toperform a pregnancy test (urine test) within 24 hours prior to the study interventionand need at least one simple acceptable contraceptive method)
  • Participants with hypersensitivity or allergy to lidocaine, prilocaine, tetracaine orauxiliary supplies contained in either EMLA® 5% cream or lidocaine-23%-tetracaine-7%gel.
  • Participants with peripheral neuropathy (over 4/10 insensitive points with Semmesmonofilament) are excluded due to disturbed pain perception, which could potentiallyinfluence the results.
  • Participants that were previously included in this clinical trial
  • Participants with a total wound area larger than 200 cm2

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: IMP2 (lidocaine-23%-tetracaine-7% gel)
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Department of Dermatology, University Hospital of Zurich, Switzerland

    Zurich, CH-8091
    Switzerland

    Active - Recruiting

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