The UltraHeal Study is a randomized controlled trial to compare healing response of low frequency contact ultrasonic-assisted debridement in addition to best practice wound care to best practice wound care alone in a Vascular Surgery Clinic patient population with wounds of the lower extremity.
The study will also investigate the bacterial tissue burden and protease activity to provide further insight into the infection and inflammation aspects of healing barriers in a challenging population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
Ultrasound-assisted wound debridement with saline irrigant applied for 5 - 15 minutes until visible and removable non-viable appearance tissue is removed to reveal a healthy appearance wound bed.
Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.
The Ottawa Hospital Wound Healing Centre
Ottawa, Ontario, Canada
Change in wound surface area
The wound surface area will be measured weekly once treatment is initiated, with a final measurement 12 weeks after initiation of therapy.
Time frame: Weekly for 4 weeks then at 12 weeks.
Protease activity
A wound swab to test for elevated protease activity will be obtained before treatment and at week5 (after the 4 weekly treatments), and then again at week 12 to ascertain the immediate and sustained impact on inflammatory aspects of wound healing.
Time frame: Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.
Bacterial burden
A tissue culture to test for elevated bacterial activity and species identification will be obtained before treatment and at week 5 (after the 4 weekly treatments), and then again at week 12 to ascertain the immediate and sustained impact on infection aspects of wound healing
Time frame: Pre-treatment, week 5 and week 12
Number of wounds healed
We will count the number of wounds that have healed and have not healed for each group and compare to ascertain if the therapy improves healing.
Time frame: Throughout duration of the study
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