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

Juerg Hafner

Status and phase

Enrolling

Phase 2

Conditions

Ulcer, Leg

Ecthyma

Ulcer Venous

Ulcus Cruris

Treatments

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

Drug: IMP1 (EMLA 5% cream)

Study type

Interventional

Funder types

Other

Identifiers

NCT05890703

LIDOTETRA

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants between 18 years and 90 years
Chronic leg ulcer(s) (duration > 4 weeks) with biofilm or necrotic layers which require 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 study protocol (cognition)
Proficiency in German, oral and written information

Exclusion criteria

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