跳至主要内容
临床试验/NCT02467998
NCT02467998Unknown不适用

The Registry of Negative Pressure Wound Therapy for Chronic Wounds and Ulcers

U.S. Wound Registry1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50,000
试验地点
1
主要终点
Healing

研究概览

简要总结

The goal of the Negative Pressure Wound Therapy Registry (NPWTR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the effectiveness and safety of various NPWT devices and methods among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these Randomized Controlled Trials (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among typical patients. Patient registries are also ideal for assessing long term safety issues in these devices.

详细描述

The purpose of the Negative Pressure Wound Therapy Registry (NPWTR)) for Wounds and Ulcers is to provide comparative effectiveness data on NPWT including different NPWT devices, and safety data on NPWT (e.g. the frequency of adverse events experienced by typical NPWT patients).

NPWT promotes wound healing by applying a vacuum through a special sealed dressing. The mechanical micro-deformation of the wound bed in response to suction has been shown to stimulate and accelerate the formation of new blood vessels (angiogenesis). The continuous vacuum removes fluid and reduces edema, thereby increasing tissue oxygen levels. The vacuum may be applied continuously or intermittently, depending on the type of wound being treated and the clinical objectives. Depending on the NPWT device, a variety of dressings are placed into the wound bed in conjunction with NPWT, and a variety of suction pressures may be applied.

The diversity of NPWT devices and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. Effectiveness in real world patients is the best current option to understand the role of NPWT in wound healing.

Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives including participation in PQRS, and to meet their Stage 2 Meaningful use criteria. The NPWTR is a subset of the USWR (Chronic Disease Registry) data. All patient data from all participating outpatient clinics are transmitted to the USWR where data are available for benchmarking, PQRS and other initiatives. Data used for comparative effectiveness research is HIPAA de-identified.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Provision of NPWT

排除标准

  • •patients not undergoing NPWT

结局指标

主要结局

Healing

时间窗: In days from the start of NPWT until the date healing or closure by other means, or of death from any cause, whichever came first, assessed up to 12 months

Time-to-event for wound closure

次要结局

  • Duration of NPWT(In days from date of NPWT initiation until the date of last NPWT treatment regardless of patient outcome, assessed up to 12 months)
  • Side effects and adverse Events During Therapy(Events occurring between initial treatment and cessation of NPWT treatment. Event outcome information will be as recorded or status at 30 days following onset)

研究者

发起方
U.S. Wound Registry
申办方类型
Other
责任方
Sponsor

研究点 (1)

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