Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing (UltraHeal)
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|ClinicalTrials.gov Identifier: NCT01973361|
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : October 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|WOUNDS||Device: Ultrasound debridement Device: Best practice wound care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial to Investigate if Application of Low Frequency Ultrasound-assisted Debridement May Improve Healing and Infection Outcomes for the Person With Vasculopathy and Recalcitrant Wounds of the Lower Extremity|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Ultrasound debridement
Participants receiving ultrasound assisted debridement in addition to best practice wound care.
Device: Ultrasound debridement
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.
Other Name: Misonix Sonic One Ultrasound Wound Care System
Active Comparator: Best Practice wound care
Participants receiving best practice wound care alone
Device: Best practice wound care
Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.
- Change in wound surface area [ Time Frame: Weekly for 4 weeks then at 12 weeks. ]The wound surface area will be measured weekly once treatment is initiated, with a final measurement 12 weeks after initiation of therapy.
- Protease activity [ Time Frame: Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks. ]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.
- Bacterial burden [ Time Frame: Pre-treatment, week 5 and week 12 ]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
- Number of wounds healed [ Time Frame: Throughout duration of the study ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973361
|The Ottawa Hospital Wound Healing Centre|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Principal Investigator:||Christine A. Murphy, MClSc PhD(c)||The Ottawa Hospital|