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Ultrasonic Wound Debridement vs. Standard Sharp Debridement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01237392
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, 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.

Condition or disease Intervention/treatment
Chronic Skin Ulcers Device: Contact ultrasonic debridement device

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : June 2008
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Contact Ultrasonic Debridement Device Device: Contact ultrasonic debridement device
Cavitational ultrasound wound debridement device
Other Name: SonicOne, Misonix Inc, Farmingdale NY
Active Comparator: Standard Sharp Debridement Device: Contact ultrasonic debridement device
Cavitational ultrasound wound debridement device
Other Name: SonicOne, Misonix Inc, Farmingdale NY



Primary Outcome Measures :
  1. Time to complete wound closure [ Time Frame: 12 and 24 weeks ]

Secondary Outcome Measures :
  1. Relative rate of wound healing [ Time Frame: 8, 12 and 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237392


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

Responsible Party: Oscar M. Alvarez, PhD, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier: NCT01237392     History of Changes
Other Study ID Numbers: NYSDH-Dbr-06-08
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY:
wound debridement
requiring debridement

Additional relevant MeSH terms:
Skin Ulcer
Skin Diseases