The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.
The primary objective is to evaluate the percentage of wounds progressing to healing at the end of the treatment period. The study will also evaluate the percentage of granulation tissue, pain experienced on dressing change and safety by way of incidence and nature of device-related or procedure-related Adverse Events and Device Deficiencies.
Study Type
OBSERVATIONAL
Enrollment
7
RENASYS Film with AIRLOCK Technology intended for use with Smith+Nephew RENASYS NPWT Systems
Lawson Health Research Institute
London, Ontario, Canada
Wound Care Plus Research and Education Center
San Juan, PR, Puerto Rico
Wound Healing Status
Progression of wound healing will be assessed by the treating clinician and compared to the wound at treatment Day 0 (baseline) by recording on a 4-point Likert scale as: * "Wound healed" * "Wound progressing to healing" * "Wound static" * "Wound deteriorating" Any subject responding within the 2 categories of "Wound healed" or "Wound progressing to healing" will be considered a success.
Time frame: End of treatment period, up to 3 weeks
Percentage Reduction in Wound Volume from Baseline to Week 3
Percentage reduction in wound volume as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Time frame: Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound Area from Baseline to Week 3
Percentage reduction in wound area as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Time frame: Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound depth from Baseline to Week 3
Percentage reduction in wound depth as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Time frame: Day 0, 1, 2, and 3 Weeks
Percentage Area of Wound Bed Covered with Granulation Tissue
The percentage of the wound bed covered with granulation tissue will be summarised using continuous summary statistics at day 0, weeks 1, 2 and 3 for each wound type and overall.
Time frame: Day 0, 1, 2, and 3 Weeks
Peri-wound Pain Scores at Dressing Removal
Pain scores on removal of the dressing specifically from the peri-wound skin will be assessed using a 0-100 Visual Analog Scale (VAS) scale, with zero (0) indicating no pain and 100 indicating the worst possible pain.
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Time frame: Day 0, 1, 2, and 3 Weeks