Ultrasonic Wound Debridement vs. Standard Sharp Debridement

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01237392

Enrollment

Registered

2010-11-09

Start date

2008-06-30

Completion date

2011-04-30

Last updated

2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Skin Ulcers

Keywords

wound debridement, requiring debridement

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.

Interventions

DEVICEContact ultrasonic debridement device

Cavitational ultrasound wound debridement device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Time to complete wound closure	12 and 24 weeks

Secondary

Measure	Time frame
Relative rate of wound healing	8, 12 and 24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026