Clincosm LogoSign in Get a demo

Ultrasonic Wound Debridement vs. Standard Sharp Debridement

Sponsor
Calvary Hospital, Bronx, NY (Other)
Overall Status
Completed
CT.gov ID
NCT01237392
Collaborator
(none)
75
Enrollment
1
Location
2
Arms
34
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Contact ultrasonic debridement device
 N/A

Study Design

Study Type:
Interventional
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 :
Jun 1, 2008
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to complete wound closure [12 and 24 weeks]

    Secondary Outcome Measures

    1. Relative rate of wound healing [8, 12 and 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oscar M. Alvarez, PhD, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY
    ClinicalTrials.gov Identifier:
    NCT01237392
    Other Study ID Numbers:
    • NYSDH-Dbr-06-08
    First Posted:
    Nov 9, 2010
    Last Update Posted:
    Jul 24, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Oscar M. Alvarez, PhD, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY
    wound debridement
    requiring debridement
    Additional relevant MeSH terms:
    Skin Ulcer

    Study Results

    No Results Posted as of Jul 24, 2014