An interventional study of Ultrasound debridement and Best practice wound care in WOUNDS, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-22.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 78 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For example:
Participants receiving ultrasound assisted debridement in addition to best practice wound care.
Device: Ultrasound debridement
Participants receiving best practice wound care alone
Device: Best practice wound care
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.
Also known as: Misonix Sonic One Ultrasound Wound Care System
Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.
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
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute