Ultrasonic Wound Debridement vs. Standard Sharp Debridement

Calvary Hospital, Bronx, NY

Status: Completed

Conditions: Chronic Skin Ulcers

Treatments: Device: Contact ultrasonic debridement device

Study type: Interventional

Funder types: Other

Identifiers

NCT01237392

NYSDH-Dbr-06-08

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Contact Ultrasonic Debridement Device

Active Comparator group

Treatment:

Device: Contact ultrasonic debridement device

Standard Sharp Debridement

Active Comparator group

Treatment:

Device: Contact ultrasonic debridement device