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OpenTrials
Completed

NCT Number: NCT01237392

Ultrasonic Wound Debridement vs. Standard Sharp Debridement

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.

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Key information

Conditions

Chronic Skin Ulcers

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calvary Hospital Center for Curative and Palliative Wound Care

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contact ultrasonic debridement device

Device

Cavitational ultrasound wound debridement device

Other names: SonicOne, Misonix Inc, Farmingdale NY

Primary outcomes

  1. Time to complete wound closure

    Time frame: 12 and 24 weeks

Secondary outcomes

  1. Relative rate of wound healing

    Time frame: 8, 12 and 24 weeks

Sponsors and collaborators

Lead sponsor

Calvary Hospital, Bronx, NY

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2010
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.