A Randomised Cross-over Clinical Evaluation to Compare Performance of ALLEVYN◊ Life and Mepilex™ Border Dressings on Patient Well-being Related Endpoints.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subjective rating of the impact of the dressing performance and characteristics on patient wellbeing (referred to as patient wellbeing score)
研究概览
简要总结
ALLEVYN◊ Life and Mepilex™ Border are both layered foam dressings with a silicone adhesive wound contact layer. Both are indicated for the same uses; however ALLEVYN◊ Life has a number of attributes designed to meet a range of characteristics associated with principles of wellbeing.
The aim for this evaluation is to assess, in a clinical setting and against a number of identified criteria, the performance of the ALLEVYN◊ Life dressing compared to Mepilex™ Border in terms of characteristics of the attributes of wellbeing.
◊ Trademark of Smith & Nephew
™ All trademarks acknowledged
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Patients ≥18 years old
- •Males and females (females must not be pregnant and must use contraception if of child bearing potential.)
- •Presence of a single suitable wound which can be the reference wound without treatment impacting on any other wound(s) on the patient.
- •Presence of a suitable wound which can be treated with the available sizes and shapes of ALLEVYN◊ Life (10.3cm X 10.3cm, 12.9cm X 12.9cm, 15.4cm X 15.4cm, 21cm X 21cm) and Mepilex™ Border (7cm X 7.5cm, 10cm X 12.5cm, 15cm X 17.5, 17cm X 20cm)
- •Presence of an exuding wound of at least 6 weeks duration at the point of enrolment, healing by secondary intention
- •The patient is able to understand the evaluation and is willing to consent to the evaluation.
- •The patient is available to participate for the anticipated duration of the evaluation.
排除标准
- •Patients with confirmed or suspected clinically infected reference wounds.
- •Patients with wounds that, in the opinion of the clinician, is likely to heal within a time period of 4 weeks from point of enrolment.
- •Patients with a reference wound undergoing treatment with compression therapy.
- •Patients where a reference wound cannot be treated in isolation from other wounds.
- •Patients with deep reference wounds that, in the opinion of the clinician, necessitate filler material.
- •Patients with a known sensitivity to any of the constituents of the evaluation products.
- •Patients with a known history of poor compliance with medical treatment.
- •Patients who have participated in this evaluation previously and have been withdrawn from the study.
- •Patients unable to understand or speak the English language.
- •Patients without the capacity to understand and answer wellbeing related questions
- •Females who are pregnant or breast feeding.
研究组 & 干预措施
Self adhesive foam dressing
Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol.
干预措施: Self adhesive foam dressing (Device)
Comparator self adhesive foam dressing
Non Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol.
干预措施: Self adhesive foam dressing (Device)
结局指标
主要结局
Subjective rating of the impact of the dressing performance and characteristics on patient wellbeing (referred to as patient wellbeing score)
时间窗: After (up to) 10 days of dressing wear
The primary outcome, a subjective patient wellbeing/preference score, is calculated using a combination of responses from 8 individual questions on a patient questionnaire and 2 further dressing retention related measures at the end of treatment with each dressing (up to maximum of 10 days). Individual patient questions relate to the effect of specific dressing performance /characteristics on patient wellbeing (each on a 0-10 scale: 0 = most negative response, 10 = most positive response).
次要结局
未报告次要终点