Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Wounds

Summary

The purpose of this study is to assess the difference in the percent reduction in wound surface area, without surgery, of chronic pressure ulcers of the pelvic region for Negative Pressure Wound Therapy (NPWT) compared to the standard dressing. This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens and compare the efficacy, safety, effectiveness and cost-effectiveness.

Conditions

• Skin Ulcer
• Pressure Ulcer

Interventions

OTHER

Standard Dressings

Participants will receive standard dressings changes as needed. Different dressing types (e.g., silver, simple gauze, hydrogel, foam, creams, gels) will be used dependent on the type of the wound (e.g., dry, wet, and intermediate).

DEVICE

Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])

Participants will receive negative pressure wound therapy.

Sponsors & Collaborators

• Ontario Ministry of Health and Long Term Care

  collaborator OTHER_GOV

• Unity Health Toronto

  collaborator OTHER

• Women's College Hospital

  collaborator OTHER

• Hamilton Niagara Haldimand Brant Community Care Access Centre

  collaborator OTHER

• Toronto Central Community Care Access Centre

  collaborator OTHER

• St. Joseph's Healthcare Hamilton

  lead OTHER

Principal Investigators

• Ron Goeree, MA · Programs for Assessment of Technology in Health Research Institute

• James Mahoney, MD · Unity Health Toronto

• Gary Sibbald, MD · Women's College

• Maureen Kitson · Niagara Region Community Care Access Centre

• Joanne Greco, BScN · Toronto Central Community Care Access Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2010-05-31

Completion

2010-05-31

Countries

• Canada

Study Locations