Recruiting

Negative Pressure Wound Therapy

Sponsor:

U.S. Wound Registry

Code:

NCT02467998

Conditions

Diabetic Foot Ulcers

Venous Stasis Ulcer

Pressure Ulcer

Surgical Wound Dehiscence

Burns

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

NPWT

Study Details

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

Study ID

NCT02467998

Start date

Jan, 2005

Status verified date

Apr, 2018

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of NPWT

Exclusion Criteria:

  • patients not undergoing NPWT

Study Design

Enrollment

50000 participants

Anticipated

Interventions and Outcome Measures

Arms

NPWT treated wounds

NPWT from any FDA cleared NPWT device including

Interventions

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

Primary outcome measure

  • Healing [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Caroline E Fife, MD

800-603-7896cfife@uswoundregistry.com

Monica Weir

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

Locations

St. Luke's Wound Care Clinic

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

Sherrill White Wolfe

936-266-2150swhitewolfe@stlukeshealth.org

More Information

Sponsor

U.S. Wound Registry

Last update posted

May 1, 2018

Last verified

Apr, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by U.S. Wound Registry on 2018-05-01.