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.
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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.
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