Investigating Ultrasound Debridement in Wound Care

Ultrasound Debridement In Chronic Lower Extremity Wounds - A Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Other: STANDARD CARE GROUP; Procedure: ULTRASOUND DEBRIDEMENT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	Other: 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.
EXPERIMENTAL: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Healing of the wound	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biofilm microbiome	Shift in biofilm to reflect wound healing	8 weeks
Reduction in bacterial colonization	Decreased bacterial colonization to reflect wound healing	8 weeks

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Karen Cross, MD, PhD, Staff Plastic Surgeon

Publications and helpful links

General Publications

• Alguire PC, Mathes BM. Skin biopsy techniques for the internist. J Gen Intern Med. 1998 Jan;13(1):46-54. doi: 10.1046/j.1525-1497.1998.00009.x.
• Altland OD, Dalecki D, Suchkova VN, Francis CW. Low-intensity ultrasound increases endothelial cell nitric oxide synthase activity and nitric oxide synthesis. J Thromb Haemost. 2004 Apr;2(4):637-43. doi: 10.1111/j.1538-7836.2004.00655.x.
• Gardner SE, Frantz RA, Saltzman CL, Hillis SL, Park H, Scherubel M. Diagnostic validity of three swab techniques for identifying chronic wound infection. Wound Repair Regen. 2006 Sep-Oct;14(5):548-57. doi: 10.1111/j.1743-6109.2006.00162.x.
• Miller CN, Newall N, Kapp SE, Lewin G, Karimi L, Carville K, Gliddon T, Santamaria NM. A randomized-controlled trial comparing cadexomer iodine and nanocrystalline silver on the healing of leg ulcers. Wound Repair Regen. 2010 Jul-Aug;18(4):359-67. doi: 10.1111/j.1524-475X.2010.00603.x.
• Sibbald RG, Woo K, Ayello EA. Increased bacterial burden and infection: the story of NERDS and STONES. Adv Skin Wound Care. 2006 Oct;19(8):447-61; quiz 461-3. doi: 10.1097/00129334-200610000-00012.
• Wu YC, Kulbatski I, Medeiros PJ, Maeda A, Bu J, Xu L, Chen Y, DaCosta RS. Autofluorescence imaging device for real-time detection and tracking of pathogenic bacteria in a mouse skin wound model: preclinical feasibility studies. J Biomed Opt. 2014 Aug;19(8):085002. doi: 10.1117/1.JBO.19.8.085002.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (ACTUAL): May 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: biofilm; chronic wound; diabetic foot ulcer; ultrasound debridement
• Other Study ID Numbers: 16-187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No