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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ecthyma, Ulcus Cruris, Ulcer, Leg, Ulcer Venous

Intervention / Treatment
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* Drug: IMP2 (lidocaine-23%-tetracaine-7% gel)
* Drug: IMP1 (EMLA 5% cream)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMP2 (lidocaine-23%-tetracaine-7% gel)<br> | Drug: IMP2 (lidocaine-23%-tetracaine-7% gel)<br>* Applied in a 2 mm thick even layer for 30 minutes on the ulcer with an occlusive dressing. During the second treatment the same dose is applied. Immediately after removal of the occlusive dressing, the rest of the preparation will be removed and sharp debridement will be performed. In order to minimise bias in this crossover trial, the localisation of start (most distal part of Wound) of sharp debridement and the sequence of sharp debridement (if more than one wound; from the largest to the smallest) is defined in the first visit.<br>|
| Active Comparator: IMP1 (EMLA 5% cream)<br> | Drug: IMP1 (EMLA 5% cream)<br>* Applied in a 2 mm thick even layer for 30 minutes on the ulcer with an occlusive dressing. During the second treatment the same dose is applied. Immediately after removal of the occlusive dressing, the rest of the preparation will be removed and sharp debridement will be performed. In order to minimise bias in this crossover trial, the localisation of start (most distal part of Wound) of sharp debridement and the sequence of sharp debridement (if more than one wound; from the largest to the smallest) is defined in the first visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local anaesthetic efficacy | Local anaesthetic efficacy during sharp wound debridement will be assessed with Visual Analogue Scale for pain 15 seconds after start of sharp debridement or earlier in case debridement is completed in less than 15 seconds or early terminated due to intolerable pain. | 15 seconds after start of sharp debridement, pain will be assessed with Visual Analogue Scale | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMLA, Lidocain, Tetracain, Leg ulcer, Sharp Wound Debridement, Anesthesia