Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Questionnaire regarding the satisfaction using the device
研究概览
简要总结
Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.
详细描述
The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds.
Using DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.
Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •male or female, ≥18 years
- •presence of an exuding wound, according to the clinician's assessment
- •the wound is deemed suitable for treatment with DryMax Sensor
- •an appropriate dressing size is available to be used according to the size of the wound
- •the participant has given a written informed consent to participate in the study.
排除标准
- •known pregnancy at the inclusion visit
- •known or suspected hypersensitivity to the DryMax Sensor or its components
- •mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study
- •ongoing treatment with systemic antibiotics
- •illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study, and/or the dressing.
结局指标
主要结局
Questionnaire regarding the satisfaction using the device
时间窗: Through study completion, up to 4 weeks
Scale 1-5 where 1= low, 5 = good
Questionnaire regarding workflow of the clinical procedure for dressing change
时间窗: Enrollment to study completion (4 weeks)
Yes/no questions and questions with multiple choices
Registration of device deficiencies
时间窗: Enrollment to study completion (4 weeks)
Severity scale 1-3, 1=low, 3=high
次要结局
- Measurement of wound size with a ruler(Enrollment to study completion (4 weeks))
- Number of days between visits(Enrollment to study completion (4 weeks))
- Questionnaire regarding leakage, strike-through, exudate viscosity(Enrollment to study completion (4 weeks))
- Weight of dressing after use using a balance(Enrollment to study completion (4 weeks))
- Questionnaire regarding wound status(Enrollment to study completion (4 weeks))
- Registration of time for display activation(Enrollment to study completion (4 weeks))
研究者
Fredrik Iredahl
Principal Investigator
Vårdcentralen Åby