The Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Partial-thickness Wounds Caused by Moisture-associated Skin Damage Compared to Usual Wound Care Treatment in Hospitals: a Multi-centre RCT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Time to complete epithelialization
研究概览
简要总结
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment.
Methodology:
RESEARCH DESIGN: A randomized controlled multicentre clinical trial.
DATA COLLECTION:
Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced Skin Protectant or local hospital partial-thickness wound (MASD) treatment protocol, yielding one study group. Due to the obvious differences between the comparative hospital wound care treatment products and the study device, the study nurses cannot be blinded. A blinded assessor will centrally assess the time to healing and other healing outcomes based on the photographs of the study area.
Study area: Defined as all partial-thickness, skin damaged areas on the body - due to exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula effluent or digestive secretions.
Study duration: 21 days or until complete healing of the moisture associated skin damage (complete epithelialization).
Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the study nurses. Relevant wound and patient information will be recorded (incontinence status, presence of a urinary catheter or faecal management system, number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma, number of applications regarding Cavilon Advanced Skin Protectant or usual hospital wound treatment protocol). Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. Therefore, daily photographs will be taken with each daily skin assessment after removal of all visual product to ensure blinded skin assessment by the central reviewer.
Pain assessment: The Numeric Rating Scale (NRS) or Crital care Pain Observation Tool (CPOT) will be used to assess pain daily. Treatment-related pain (pain experienced during treatment (cleansing and product application)) and wound related pain (pain perception specifically caused by the MASD lesion) will be assessed.
Nursing time assessment: Time per cleansing and time per treatment application.
详细描述
Problem statement:
Partial-thickness wounds (erosion/denudation of the epithelial and dermal layers of the skin) can occur due to prolonged exposure of moisture and irritants. Various sources of moisture can cause these superficial wounds called moisture-associated skin damage (MASD) which include wound exudate, bodily fluids from incontinence and effluent from stomas and fistulas. MASD can present as inflammation with or without erosion and even secondary infection. Partial-thickness denudation can be extremely painful and detrimental to the patient. Traditionally a wide array of treatment options is used in clinical practice, yet there is a lack of robust studies comparing newer technologies with current practices. 3M™ Cavilon™ Advanced Skin Protectant, launched in 2017, is a newer cyanoacrylate-based medical device indicated for treatment of partial-thickness skin loss and is the only cyanoacrylate-based barrier product available on the Belgian market.
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment.
Methodology:
RESEARCH DESIGN: A randomized controlled multicentre clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Single: Investigator (central assessor of the photographs) will be blinded.
The participants and care providers cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or their legally authorized representative signed informed consent.
- •The patient is expected to be in the study for the full duration of the trial.
- •The patient has partial thickness wounds caused by moisture (MASD) i.e.,
- •The patient has IAD category 2A or
- •Peri-wound MASD or
- •Peri-stomal MASD.
排除标准
- •Patients with a known hypersensitivity or allergy to acrylate or cyanoacrylate.
- •The patient requires topical treatment due to a fungal, bacterial or viral infection in the study area.
- •Intertriginous dermatitis (most often a fungal infection is present).
- •Peri-fistula MASD (would usually require hospitalization).
- •The patient has any other local dermatological disease or skin condition interfering with this study.
- •Patients participating in another study with a known or implied effect on skin barrier function.
- •Patients who are receiving end-of-life care.
结局指标
主要结局
Time to complete epithelialization
时间窗: Day 01 - Day 21
Number of days from commencement of application of study device or comparator to the study area to complete resolution of partial-thickness wound
次要结局
- Proportion of participants with complete epithelialization(Day 07, Day 14, Day 21)
- Change in maceration surface area(Day 07, Day 14, Day 21)
- Mean change in treatment related pain(Day 01 - Day 21)
- Mean change in wound pain(Day 01, Day 02, Day 04, Day 07)
- Total treatment cost(Day 04, Day 07)