Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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.