Pressure Ulcer Clinical Trial
Official title:
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 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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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