Ultrasonic Wound Debridement vs. Standard Sharp Debridement
Not Applicable
Completed
- Conditions
- Chronic Skin Ulcers
- Interventions
- Device: Contact ultrasonic debridement device
- Registration Number
- NCT01237392
- Lead Sponsor
- Calvary Hospital, Bronx, NY
- Brief Summary
A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- Chronic wound needing debridement >3 cm2
- Ulcer history >4mo
- Adequate arterial blood flow (ABI>0.7)
- Venous, Inflammatory, Pressure, Diabetic
Exclusion Criteria
- Bleeding disorder
- ABI<0.7
- Uncontrolled diabetes
- Taking systemic corticosteroids
- Chemotherapy
- Participating in another study
- Treatment with Apligraft, Dermagraft, or Regranex within 90 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Contact Ultrasonic Debridement Device Contact ultrasonic debridement device - Standard Sharp Debridement Contact ultrasonic debridement device -
- Primary Outcome Measures
Name Time Method Time to complete wound closure 12 and 24 weeks
- Secondary Outcome Measures
Name Time Method Relative rate of wound healing 8, 12 and 24 weeks
Trial Locations
- Locations (1)
Calvary Hospital Center for Curative and Palliative Wound Care
🇺🇸Bronx, New York, United States