Negative Pressure Wound Therapy Registry

• Conditions: Pressure Ulcer; Diabetic Foot Ulcers; Venous Stasis Ulcer; Other Types of Chronic Non Healing Wounds; Surgical Wound Dehiscence; Burns
• Interventions: Device: NPWT

• Registration Number: NCT02467998
• Lead Sponsor: U.S. Wound Registry

Brief 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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01
• Primary Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• Provision of NPWT

Exclusion Criteria

• patients not undergoing NPWT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NPWT treated wounds	NPWT	NPWT from any FDA cleared NPWT device including

Primary Outcome Measures

Name	Time	Method
Healing	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

Secondary Outcome Measures

Name	Time	Method
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	Counting total amount of therapy delivered
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	Overall catalog of event types and occurrences. Score in % for: bleeding, retention of foam or other interface in wound bed, periwound breakdown, worsening of wound such as exposure of deep structure, and wound infection

Trial Locations

Locations (1)

St. Luke's Wound Care Clinic; 🇺🇸 The Woodlands, Texas, United States