Ultrasonic Wound Debridement vs. Standard Sharp Debridement

Calvary Hospital, Bronx, NY75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Skin Ulcers

Interventions

Contact ultrasonic debridement deviceDEVICE

Cavitational ultrasound wound debridement device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Calvary Hospital Center for Curative and Palliative Wound Care

The Bronx, New York, United States

Outcomes

Primary Outcomes

Time to complete wound closure

Time frame: 12 and 24 weeks

Secondary Outcomes

Relative rate of wound healing

Time frame: 8, 12 and 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.