Negative Pressure Wound Therapy Registry (NPWTR)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 50000

Contacts and Locations

Study Locations

• United States
  • Texas
    • The Woodlands, Texas, United States, 77384
      • Recruiting
      • St. Luke's Wound Care Clinic
      • Contact: Sherrill White Wolfe; Phone Number: 936-266-2150; Email: swhitewolfe@stlukeshealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing treatment with NPWT

Description

Inclusion Criteria:

• Provision of NPWT

Exclusion Criteria:

• patients not undergoing NPWT

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NPWT treated wounds; NPWT from any FDA cleared NPWT device including	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; Other Names: Renasys; Avance; SNaP; Pico; the VAC; Engenix; Sved; extriCARE; Prospera; Invia Liberty; Invia Motion; Halo MINI; COBALTT; Halo XT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing	Time-to-event for wound closure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of NPWT	Counting total amount of therapy delivered	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	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	Events occurring between initial treatment and cessation of NPWT treatment. Event outcome information will be as recorded or status at 30 days following onset

Collaborators and Investigators

• Sponsor: U.S. Wound Registry
• Investigators: Principal Investigator: Caroline Fife, MD, US Wound Registry

Publications and helpful links

General Publications

• Fife CE, Carter MJ. Wound Care Outcomes and Associated Cost Among Patients Treated in US Outpatient Wound Centers: Data From the US Wound Registry. Wounds. 2012 Jan;24(1):10-7.
• Fife CE, Walker D, Thomson B, Otto G. The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111/j.1742-481X.2008.00467.x.
• Fife CE, Otto G, Walker D, Turner T, Smith L. Healing dehisced surgical wounds with negative pressure wound therapy. Ostomy Wound Manage. 2004 Apr;50(4A Suppl):28-31. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: NPWT; electronic health records; PQRS; meaningful use; structured language
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Postoperative Complications; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Surgical Wound; Varicose Ulcer; Pressure Ulcer; Surgical Wound Dehiscence
• Other Study ID Numbers: CDR003