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Negative Pressure Wound Therapy Registry

NCT02467998 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50000

Last updated 2018-05-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • U.S. Wound Registry

    lead OTHER

Principal Investigators

  • Caroline Fife, MD · US Wound Registry

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2020-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02467998 on ClinicalTrials.gov