Investigating Ultrasound Debridement in Wound Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The initial step of wound management, debridement, is thought to be critical in promoting wound healing. Of the numerous debridement modalities, ultrasound seems to hold promising results in accelerate healing in our own clinical experience here at St. Michael's Hospital. In brief, ultrasound debridement is a method of removing devitalized tissue through microstreaming and cavitational effects. The non-thermal energy up-regulates cellular activity and promotes growth factor and protein synthesis, fibrinolysis, and is anti-bacterial . The technology selectively emulsifies dead and dying tissues with micro-sized gas bubbles, stimulates membranes of surrounding healthy cells, and renders bacteria more susceptible to antibiotic treatment. Thus, in addition to creating an optimal environment, the modality also serves to promote the process of healing. A systematic review and meta-analysis by Voigt et al. (2011) examined the use of low-frequency (20-30 kHz) ultrasound in randomized-controlled trials. It was found that low or high-intensity delivery of low-frequency ultrasound both promoted early healing in lower-extremity wounds. At St. Michael's Hospital, ultrasound debridement is already being used in the wound clinic with promising results. However, objective comparisons need to be made to validate our clinical observations. The goal of the proposed pilot study is to assess the feasibility of our current study design. The information gathered will allow us to refine the research methodology for the development of a larger-scale study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasonic Wound Debridement vs. Standard Sharp Debridement

NCT01237392

Chronic Skin Ulcers

COMPLETED NA

Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)

NCT04633642

Diabetic Foot Ulcer

COMPLETED NA

Effect of Insulin Therapy by Ultrasonography in Wound Healing of Chronic Diabetic Patients

NCT06708975

Diabetes Mellitus

NOT_YET_RECRUITING NA

Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

NCT01973361

WOUNDS

COMPLETED NA

Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes

NCT03041844

Diabetic Foot Ulcer Venous Ulcer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Ultrasound debridement is a method of removing devitalized tissue through microstreaming and cavitational effects. The non-thermal energy up-regulates cell activity and promotes growth factor and protein synthesis, fibrinolysis, and is anti-bacterial. The technology selectively emulsifies dead and dying tissues with micro-sized gas bubbles, stimulates membranes of surrounding healthy cells, and render bacteria more susceptible to antibiotic treatment. Thus, in addition to creating an optimal environment, the modality also serves to promote the process of healing. At St. Michael's Hospital, ultrasound debridement is already being used in the wound clinic with promising results. However, objective comparisons need to be made to quantify and qualify our clinical observations. The goal of the proposed pilot study is to assess feasibility of our current study design and allow us to refine the research methodology for the development of a larger-scale study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STANDARD CARE GROUP

The subject positioned so absorbent pads are in position to catch irrigation solution. The saline bottle will be held 10-15 cm from wound bed, and squeezed to spray all surfaces of wound in a sweeping motion, from clean to dirty area of wound. Irrigation will be repeated as necessary to remove exudate, slough, and debris from the wound until the solution draining from the wound is clear. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into the wound cavity, undermining, or tunnel to fill the dead space without causing the wound to stretch or bulge or be packed tightly. Packing should be in contact with entire wound base and edges. Dressings changed once every 3 days by the patient's care provider.

Group Type PLACEBO_COMPARATOR

STANDARD CARE GROUP

Intervention Type OTHER

The subject positioned so absorbent pads are in position to catch irrigation solution. The saline bottle will be held 10-15 cm from wound bed, and squeezed to spray all surfaces of wound in a sweeping motion, from clean to dirty area of wound. Irrigation will be repeated as necessary to remove exudate, slough, and debris from the wound until the solution draining from the wound is clear. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into the wound cavity, undermining, or tunnel to fill the dead space without causing the wound to stretch or bulge or be packed tightly. Packing should be in contact with entire wound base and edges. Dressings changed once every 3 days by the patient's care provider.

ULTRASOUND DEBRIDEMENT GROUP:

Low-frequency ultrasound SonicOne O.R. (Misonix, New York, US) generates ultrasound waves with 22.5 kHz frequency. Each probe is attached to a set of irrigation solution (saline 0.9%), they transform electric energy into mechanical vibrations to induce tiny particles of water from irrigation fluid. Absorbent pads are positioned to catch excess saline. With SonicOne set at continuous mode with minimum pump flow, the debridement will begin at most distal aspect of ulcer with the hand piece in constant motion until entire ulcer surface has been debrided until as much necrotic tissue has been removed. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into wound cavity.

Group Type EXPERIMENTAL

ULTRASOUND DEBRIDEMENT

Intervention Type PROCEDURE

Low-frequency ultrasound SonicOne O.R. (Misonix, New York, US) generates ultrasound waves with 22.5 kHz frequency. Each probe is attached to a set of irrigation solution (saline 0.9%), they transform electric energy into mechanical vibrations to induce tiny particles of water from irrigation fluid. Absorbent pads are positioned to catch excess saline. With SonicOne set at continuous mode with minimum pump flow, the debridement will begin at most distal aspect of ulcer with the hand piece in constant motion until entire ulcer surface has been debrided until as much necrotic tissue has been removed. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into wound cavity.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ULTRASOUND DEBRIDEMENT

Low-frequency ultrasound SonicOne O.R. (Misonix, New York, US) generates ultrasound waves with 22.5 kHz frequency. Each probe is attached to a set of irrigation solution (saline 0.9%), they transform electric energy into mechanical vibrations to induce tiny particles of water from irrigation fluid. Absorbent pads are positioned to catch excess saline. With SonicOne set at continuous mode with minimum pump flow, the debridement will begin at most distal aspect of ulcer with the hand piece in constant motion until entire ulcer surface has been debrided until as much necrotic tissue has been removed. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into wound cavity.

Intervention Type PROCEDURE

STANDARD CARE GROUP

The subject positioned so absorbent pads are in position to catch irrigation solution. The saline bottle will be held 10-15 cm from wound bed, and squeezed to spray all surfaces of wound in a sweeping motion, from clean to dirty area of wound. Irrigation will be repeated as necessary to remove exudate, slough, and debris from the wound until the solution draining from the wound is clear. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into the wound cavity, undermining, or tunnel to fill the dead space without causing the wound to stretch or bulge or be packed tightly. Packing should be in contact with entire wound base and edges. Dressings changed once every 3 days by the patient's care provider.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. Subjects with chronic (\>4 week duration) lower extremity wound (of any etiology) that have failed to improve despite using the clinic's standard approach for wound care during a 2-week period (Failure to improve is defined as less than 15% reduction in wound area)

Exclusion Criteria

1. Subjects with clinical evidence of wound infection
2. Subjects with thick eschar that has not been removed
3. Subjects with severe arterial insufficiency: Absence of pedal pulses, Ankle Brachial Index \< 0.3, Toe Pressure \< 20
4. Subjects who are receiving advanced wound therapy treatment: hyperbaric therapy, biological dressings
5. Subjects who are taking antibiotics
6. Subjects who are using systemic steroids
7. Subjects who have known contraindication to the dressing product (Acticoat®)
8. Subjects who are not able to adhere to dressing change protocol or hospital visits
9. Subjects with wound area reduction of \> 15% during the initial two-week standard care period.
10. Subjects without sufficient English language proficiency to understand the consent form.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes