Ultrasonic Wound Debridement vs. Standard Sharp Debridement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier:
NCT01237392
First received: November 8, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention
Chronic Skin Ulcers
Device: Contact ultrasonic debridement device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Calvary Hospital, Bronx, NY:

Primary Outcome Measures:
  • Time to complete wound closure [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative rate of wound healing [ Time Frame: 8, 12 and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 8, 2010
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Calvary Hospital, Bronx, NY:
wound debridement
requiring debridement

Additional relevant MeSH terms:
Skin Ulcer
Ulcer
Chronic Disease
Skin Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on August 20, 2014