Ultrasonic Wound Debridement vs. Standard Sharp Debridement
Primary Purpose
Chronic Skin Ulcers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contact ultrasonic debridement device
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Skin Ulcers focused on measuring wound debridement, requiring debridement
Eligibility Criteria
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
Sites / Locations
- Calvary Hospital Center for Curative and Palliative Wound Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Contact Ultrasonic Debridement Device
Standard Sharp Debridement
Arm Description
Outcomes
Primary Outcome Measures
Time to complete wound closure
Secondary Outcome Measures
Relative rate of wound healing
Full Information
NCT ID
NCT01237392
First Posted
November 8, 2010
Last Updated
July 22, 2014
Sponsor
Calvary Hospital, Bronx, NY
1. Study Identification
Unique Protocol Identification Number
NCT01237392
Brief Title
Ultrasonic Wound Debridement vs. Standard Sharp Debridement
Official Title
Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Calvary Hospital, Bronx, NY
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Skin Ulcers
Keywords
wound debridement, requiring debridement
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contact Ultrasonic Debridement Device
Arm Type
Active Comparator
Arm Title
Standard Sharp Debridement
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Contact ultrasonic debridement device
Other Intervention Name(s)
SonicOne, Misonix Inc, Farmingdale NY
Intervention Description
Cavitational ultrasound wound debridement device
Primary Outcome Measure Information:
Title
Time to complete wound closure
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Relative rate of wound healing
Time Frame
8, 12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar M Alvarez, PhD
Organizational Affiliation
Director, Wound care Center, Calvary Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin E Wendelken, DPM, RN
Organizational Affiliation
Physician, Wound Care Center, Calvary Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Calvary Hospital Center for Curative and Palliative Wound Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
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Ultrasonic Wound Debridement vs. Standard Sharp Debridement
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