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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
Calvary Hospital, Bronx, NY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Skin Ulcers focused on measuring wound debridement, requiring debridement

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 8, 2010
Last Updated
July 22, 2014
Sponsor
Calvary Hospital, Bronx, NY
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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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