Negative Pressure Wound Therapy Registry

NCT02467998 | Unknown DMC

• 1 other identifier: CDR003
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

meaningful use; electronic health records; structured language; NPWT; PQRS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

NPWT treated wounds

NPWT from any FDA cleared NPWT device including

Device: NPWT

Interventions

NPWT DEVICE

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

Also known as: the VAC, Renasys, Pico, Engenix, Sved, SNaP, extriCARE, Prospera, Invia Liberty, Invia Motion, Avance, Halo MINI, COBALTT, Halo XT

NPWT treated wounds

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing treatment with NPWT

You may qualify if:

• Provision of NPWT

You may not qualify if:

• patients not undergoing NPWT

Sponsors & Collaborators

• U.S. Wound Registry: lead

Study Sites (1)

St. Luke's Wound Care Clinic

The Woodlands, Texas, 77384, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 18577134 BACKGROUND

• 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.

  PMID: 25875947 BACKGROUND

• 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.

  PMID: 15317243 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Surgical Wound Dehiscence; Burns

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Caroline Fife, MD

  US Wound Registry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline E Fife, MD

CONTACT

800-603-7896; cfife@uswoundregistry.com

Monica Weir

CONTACT

800-603-7896; monica.weir@intellicure.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: June 10, 2015
• Study Start: January 1, 2005
• Primary Completion: January 1, 2020
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)