Negative Pressure Wound Therapy Registry

Burns Clinical Trial

— NPWTR  

Official title:

The Registry of Negative Pressure Wound Therapy for Chronic Wounds and Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02467998
• Other study ID #: CDR003
• Status: Recruiting
• Start date: January 2005

Study information

• Verified date: April 2018
• Source: U.S. Wound Registry
• Contact: Caroline E Fife, MD
• Phone: 800-603-7896
• Email: cfife[@]uswoundregistry.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Provision of NPWT

Exclusion Criteria:

• patients not undergoing NPWT

Related Conditions & MeSH terms

• Burns
• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Other Types of Chronic Non Healing Wounds
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Pressure Ulcer
• Surgical Wound
• Surgical Wound Dehiscence
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcer
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	St. Luke's Wound Care Clinic	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Wound Registry

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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 2:17-22. doi: 10.1111/j.1742-481X.2008.00467.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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