NCT01973361

Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• WOUNDS

Interventions

Type	Name	Description
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.
DEVICE	Best practice wound care	Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-10-31
• Last updated: 2015-10-22

Locations

1 site across 1 country: Canada