Negative Pressure Wound Therapy Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Skin and Soft Tissue Infections, Cardiology, Hospital, Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/3/2018 |
| Start Date: | January 2005 |
| Contact: | Caroline E Fife, MD |
| Email: | cfife@uswoundregistry.com |
| Phone: | 800-603-7896 |
The Registry of Negative Pressure Wound Therapy for Chronic Wounds and Ulcers
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.
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.
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.
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.
Inclusion Criteria:
- Provision of NPWT
Exclusion Criteria:
- patients not undergoing NPWT
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