Back to resultsPainless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream (LIDOTETRA)
Primary Purpose
Ulcus Cruris, Ecthyma, Ulcer, Leg
Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
IMP2 (lidocaine-23%-tetracaine-7% gel)
IMP1 (EMLA 5% cream)
Sponsored by
About this trial
This is an interventional treatment trial for Ulcus Cruris focused on measuring EMLA, Lidocain, Tetracain, Leg ulcer, Sharp Wound Debridement, Anesthesia
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
Sites / Locations
- Department of Dermatology, University Hospital of Zurich, SwitzerlandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMP2 (lidocaine-23%-tetracaine-7% gel)
IMP1 (EMLA 5% cream)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05890703
Brief Title
Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream
Acronym
LIDOTETRA
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juerg Hafner
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcus Cruris, Ecthyma, Ulcer, Leg, Ulcer Venous
Keywords
EMLA, Lidocain, Tetracain, Leg ulcer, Sharp Wound Debridement, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMP2 (lidocaine-23%-tetracaine-7% gel)
Arm Type
Experimental
Arm Title
IMP1 (EMLA 5% cream)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IMP2 (lidocaine-23%-tetracaine-7% gel)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IMP1 (EMLA 5% cream)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local anaesthetic efficacy
Description
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.
Time Frame
15 seconds after start of sharp debridement, pain will be assessed with Visual Analogue Scale
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juerg Hafner, Prof.
Phone
+41 44 255 25 33
Email
juerg.hafner@usz.ch
Facility Information:
Facility Name
Department of Dermatology, University Hospital of Zurich, Switzerland
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juerg Hafner, M.D. Prof.
Phone
+41 44 255 25 33
Email
juerg.hafner@usz.ch
First Name & Middle Initial & Last Name & Degree
Juerg Hafner, M.D. Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream
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