A 12-week, Prospective, Open-label, Randomized, Controlled Clinical Trial Comparing Negative Pressure Wound Therapy (NPWT) to Standard Wound Care for the Treatment of Chronic Pressure Wounds of the Pelvic Region

The Ontario Health Technology Advisory Committee recommended that a study should be completed due to the large numbers of patients needing chronic wound care and the increasing use of NPWT based on poor quality evidence to identify any potential indications for the use of NPWT. This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens in Ontario and the results will serve as a benchmark for the utilization of NPWT in chronic pressure wounds, establishing and providing guidance regarding the use of NPWT in this population of subjects and to support policy decision making regarding the funding of the NPWT in the province. Specifically, this will compare the efficacy, effectiveness and cost-effectiveness of NPWT with standard dressing regimens for the treatment of chronic pressure ulcers of the pelvic region.

This is a prospective, randomized, open-label, controlled clinical trial comparing standardized wound dressing (control arm) to NPWT (experimental arm) for the treatment of chronic pressure wounds of the pelvic region. NPWT will be performed using the Vacuum-Assisted Closure System (V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario). NPWT will be compared to the present recommended state of the art wound dressings in subjects who would be candidates for either type of wound therapy. Both arms will receive standard wound care (e.g., debridement, preventative care, infection control, etc.). The efficacy, effectiveness, safety, and quality of life will be evaluated for standardized wound dressing versus NPWT. Complications associated with either form of wound care will be documented. An economic evaluation will be conducted in order to assess the cost-effectiveness and cost-utility of NPWT compared to standard wound dressing. It is anticipated that 184 subjects will be enrolled and randomized over a 1.5 year period. All subjects providing consent and meeting inclusion/exclusion criteria will be randomized to either treatment arm and followed for 12 weeks. Patients who have wound closure within the 12-week study period will continue to have wound care visits as scheduled. All subjects will have Wound Evaluation Visits and Wound Dressing Change Visits. Wound Evaluation Visits will occur at baseline, 2, 4, 6, 8 and 12 weeks after the date of randomization, where following removal of the dressing, a detailed wound assessment (e.g., wound characteristics, measurements) will be done and healthcare resource utilization will be collected. Disease specific quality of life measures and preference based quality of life measures (EQ-5D) will be collected at baseline, 6 weeks and at 12 weeks. Dressing Change Visits will occur as clinically required and the frequency of dressing changes per week will be allowed to vary over the 12 weeks of the study. During the dressing change visits, subjects will be monitored for wound infection and other complications. Subjects may be enrolled and randomized in the clinic and transferred to the community with continued follow-up completed by the appropriate Community Care Access Centre.