Clinical trial NCT05890703: Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream
Official title: Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream: a Single-blind, Crossover, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ulcus Cruris
Ecthyma
Ulcer, Leg
Ulcer Venous
Keywords: EMLA
Lidocain
Tetracain
Leg ulcer
Sharp Wound Debridement
Anesthesia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Local anaesthetic efficacy
timeFrame: 15 seconds after start of sharp debridement, pain will be assessed with Visual Analogue Scale
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital of Zurich, Switzerland
Study officials:
References: