NCT02467998

Negative Pressure Wound Therapy Registry

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50,000 (estimated)
• Sponsor: U.S. Wound Registry · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Foot Ulcers
• Venous Stasis Ulcer
• Pressure Ulcer
• Surgical Wound Dehiscence
• Burns
• Other Types of Chronic Non Healing Wounds

Interventions

Type	Name	Description
DEVICE	NPWT	SVAP polyurethane foam, RENASYS foam, RENASYS gauze, AMD gauze, VAC white sponge, VAC black sponge, applied with various NPWT devices, in addition to various dressings to protect wound edges

Timeline

• Start date: 2005-01-01
• Primary completion: 2020-01-01
• First posted: 2015-06-10
• Last updated: 2018-05-01

Locations

1 site across 1 country: United States