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

Ulcer, Leg Clinical Trial

Official title: Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream: a Single-blind, Crossover, Randomised, Controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Ulcer Venous
• Ulcer, Leg
• Ulcus Cruris

• NCT number: NCT05890703
• Study type: Interventional
• Source: University of Zurich
• Contact: Juerg Hafner, Prof.
• Phone: +41 44 255 25 33
• Email: juerg.hafner@usz.ch
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Completion date: December 31, 2023