Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream: a Single-blind, Crossover, Randomised, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local anaesthetic efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IMP2 (lidocaine-23%-tetracaine-7% gel)
干预措施: IMP2 (lidocaine-23%-tetracaine-7% gel) (Drug)
IMP1 (EMLA 5% cream)
干预措施: IMP1 (EMLA 5% cream) (Drug)
结局指标
主要结局
Local anaesthetic efficacy
时间窗: 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.
次要结局
未报告次要终点
研究者
Juerg Hafner
University Hospital Zurich
University of Zurich