Ultrasonic Wound Debridement vs. Standard Sharp Debridement

July 22, 2014 updated by: Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Calvary Hospital Center for Curative and Palliative Wound Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Contact Ultrasonic Debridement Device
Device: Contact ultrasonic debridement device
Cavitational ultrasound wound debridement device
Other Names:
  • SonicOne, Misonix Inc, Farmingdale NY
Active Comparator: Standard Sharp Debridement
Device: Contact ultrasonic debridement device
Cavitational ultrasound wound debridement device
Other Names:
  • SonicOne, Misonix Inc, Farmingdale NY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to complete wound closure
Time Frame: 12 and 24 weeks
12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative rate of wound healing
Time Frame: 8, 12 and 24 weeks
8, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calvary Hospital, Bronx, NY

Investigators

  • Principal Investigator: Oscar M Alvarez, PhD, Director, Wound Care Center, Calvary Hospital
  • Study Director: Martin E Wendelken, DPM, RN, Physician, Wound Care Center, Calvary Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYSDH-Dbr-06-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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