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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcer, Leg; Ulcus Cruris; Ulcer Venous; Ecthyma
• Intervention / Treatment: Drug: IMP2 (lidocaine-23%-tetracaine-7% gel); Drug: IMP1 (EMLA 5% cream)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Juerg Hafner, Prof.; Phone Number: +41 44 255 25 33; Email: juerg.hafner@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8091
    • Recruiting
    • Department of Dermatology, University Hospital of Zurich, Switzerland
    • Contact: Juerg Hafner, M.D. Prof.; Phone Number: +41 44 255 25 33; Email: juerg.hafner@usz.ch
    • Principal Investigator: Juerg Hafner, M.D. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMP2 (lidocaine-23%-tetracaine-7% gel)	Drug: IMP2 (lidocaine-23%-tetracaine-7% gel); 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.
Active Comparator: IMP1 (EMLA 5% cream)	Drug: IMP1 (EMLA 5% cream); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Juerg Hafner

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Anesthesia; Leg ulcer; EMLA; Lidocain; Tetracain; Sharp Wound Debridement
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Skin Ulcer; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Skin Diseases, Bacterial; Pyoderma; Ulcer; Leg Ulcer; Ecthyma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Tetracaine
• Other Study ID Numbers: LIDOTETRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No