A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Feasibility and usability of device in treatment.
研究概览
简要总结
This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.
详细描述
A study of 24 completed subjects will be conducted by enrolling patients who are requiring treatment for open skin and soft tissue defects. Patients will be screened for inclusion criteria and asked to consent to participate in the study. Following consent subjects will be randomized to receive treatment of one of the two study arms. Arm 1, the standard of care arm, will receive KCI Wound VAC Granulofoam. Arm 2, the study arm, will receive treatment with NP-PWD. Prior to the initial application, wound evaluations and photography will be completed to include assessment of infection with wound swabs. The wound dressing will be assessed for the need for change every 2-3 days and changed if clinically indicated (following each device IFU). Subjects will be followed for up to nine days post initial application. At minimum, the randomized treatment will be applied for 2 days after initial application for a subject to be considered completed. Subject who do not complete the treatment course (minimum of 2 days of treatment), may be replaced per investigators discretion. Follow up data will be gathered at each change/removal of the NP-PWD or Wound VAC. The data collected will include indications for dressing change, dressing change process, photographs and assessments for wound healing, infection, and adverse events. Gathered clinical data of the enrolled subjects will be used to evaluate the feasibility in using the NP-PWD device for wound healing management.
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
- 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
- •All subjects enrolled must meet ALL the following criteria:
- •Patients 18 years of age or older of either gender
- •Have an open skin or soft tissue defect requiring treatment
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •Active malignant disease at the study site
- •Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use
- •On any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days or any previous enrollment in this study
- •Pregnant at enrollment
研究组 & 干预措施
Standard of Care Wound VAC application
Patients randomized to the standard of care arm will have the standard wound vac device applied to their wound.
干预措施: Wound Vac (Device)
NP-PWD application
Patients randomized to NP-PWD arm will have the NP-PWD device applied to their wound.
干预措施: NP-PWD (Device)
结局指标
主要结局
Feasibility and usability of device in treatment.
时间窗: Seven to nine days post application.
The number and type of issues with the device will be documented to determine feasibility and usability. Events such as complications with application, device changes and early removal and rationale for events during the period the patient has the study device applied and throughout the entire enrollment period.
次要结局
- Ease of use of device by healthcare providers(Seven to nine days post application.)
- Tolerability of the device by patient subjects(Seven to nine days post application.)
- Wound readiness for closure(Seven to nine days post application.)
- Incidence of colony forming units.(Seven to nine days post application.)