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

Phase 2

Recruiting

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

• Registration Number: NCT05890703
• Lead Sponsor: Juerg Hafner

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-17
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-05
• Last Update Submitted: 2023-06-05
• Study First Posted: 2023-06-06
• Last Update Posted: 2023-06-06
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IMP2 (lidocaine-23%-tetracaine-7% gel)	IMP2 (lidocaine-23%-tetracaine-7% gel)	-
IMP1 (EMLA 5% cream)	IMP1 (EMLA 5% cream)	-

Primary Outcome Measures

Name	Time	Method
Local anaesthetic efficacy	15 seconds after start of sharp debridement, pain will be assessed with Visual Analogue Scale	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.

Trial Locations

Locations (1)

Department of Dermatology, University Hospital of Zurich, Switzerland; 🇨🇭 Zurich, Switzerland