Investigating Ultrasound Debridement in Wound Care

NCT03516422 | Unknown

• 1 other identifier: 16-187
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes

Keywords

ultrasound debridement; diabetic foot ulcer; chronic wound; biofilm

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Healing of the wound

  8 weeks

Secondary Outcomes (2)

• Change in biofilm microbiome

  8 weeks

• Reduction in bacterial colonization

  8 weeks

Study Arms (2)

STANDARD CARE GROUP

PLACEBO COMPARATOR

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

ULTRASOUND DEBRIDEMENT GROUP:

EXPERIMENTAL

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

Interventions

ULTRASOUND DEBRIDEMENT 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.

ULTRASOUND DEBRIDEMENT GROUP:

STANDARD CARE GROUP 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.

STANDARD CARE GROUP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Related Publications (6)

• 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.

  PMID: 9462495 BACKGROUND

• 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.

  PMID: 15102020 BACKGROUND

• 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.

  PMID: 17014666 BACKGROUND

• 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.

  PMID: 20636550 BACKGROUND

• 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.

  PMID: 17008815 BACKGROUND

• 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.

  PMID: 25089944 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Officials

• Karen Cross, MD, PhD

  Staff Plastic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Cross, MD, PhD

CONTACT

416-864-6060; crosska@smh.ca

Julie Perry, MSc, PhD

CONTACT

416-864-6060; perryj@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: May 4, 2018
• Study Start: November 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share