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

NCT05890703 | Unknown Phase 2 DMC

• 1 other identifier: LIDOTETRA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcus Cruris; Ecthyma; Ulcer, Leg; Ulcer Venous

Keywords

EMLA; Lidocain; Tetracain; Leg ulcer; Sharp Wound Debridement; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

IMP1 (EMLA 5% cream)

ACTIVE COMPARATOR

Drug: IMP1 (EMLA 5% cream)

Interventions

IMP2 (lidocaine-23%-tetracaine-7% gel) DRUG

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.

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

IMP1 (EMLA 5% cream) DRUG

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.

IMP1 (EMLA 5% cream)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Juerg Hafner: lead

Study Sites (1)

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, CH-8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Foot Ulcer; Ecthyma; Leg Ulcer; Varicose Ulcer

Interventions

IGF2BP2 protein, human; signal peptide peptidase; Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Ulcer; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Pyoderma; Varicose Veins; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Juerg Hafner, Prof.

CONTACT

+41 44 255 25 33; juerg.hafner@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Hospital Zurich

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 6, 2023
• Study Start: June 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)