NCT06321978招募中不适用
Observational Study to Describe the Utilization of Foam Dressings in Routine Clinical Practice, for the Treatment of Patients With Chronic Wounds in Primary Healthcare Centers in Spain.
Molnlycke Health Care AB1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dressing use
研究概览
简要总结
The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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 aged 18 years or older.
- •The patient has been deemed by the HCP to change dressing to Mepilex® Border Flex.
- •Patients with chronic wounds (wounds that have not reduced in size by more than 40% to 50% or healed within a month) treated with foam dressings, other that Mepilex® Border Flex, according to its intended use at baseline visit for minimum 4 weeks.
- •Patients with an expectation of wound follow-up of at least 4 weeks.
- •Patients agree only to have the dressing changed by the HCP.
- •Patients capable of signing the Informed Consent Form and answer the questions being asked.
排除标准
- •Patients with any applicable contraindication or sensibilization to any of the dressing compounds
- •Patients with pressure ulcers (PU) stage I, deep tissue injuries or terminal wounds (e.g., fungating wounds)
- •Patients with wounds whose location and/or aetiology requires a dressing change for reasons that are unrelated to the dressing characteristics such as wounds in the sacral area.
- •Hospice patients
- •Patients participating in other studies interfering with this study.
结局指标
主要结局
Dressing use
时间窗: 4 weeks
Number of dressings used the week before baseline visit compared to the number of dressings used the week before follow-up visit.
次要结局
- Wound characteristics(4 weeks)
- Costs(4 weeks)
- Wound management(4 weeks)
- Technical Performance (HCP evaluation)(4 weeks)
- Patient Experience (PRO)(4 weeks)
研究者
研究点 (1)
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