MIST ULTRASOUND HEALING OF WOUNDS USING MIST ULTASOUND TO ACCELERATE THE HEALING OF WOUNDS AND DEEP TISSUE INJURIES: A CASE–STUDY ___________________________________________________________________________ A Case-Study Presented to The Faculty of the College of Health Professions Florida Gulf Coast University In Partial Fulfillment of the Requirement for the Degree of Transition Doctorate of Physical Therapy ___________________________________________________________________________ By Justin Bovee, MSPT 2015
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MIST ULTRASOUND HEALING OF WOUNDS
USING MIST ULTASOUND TO ACCELERATE THE HEALING OF WOUNDS AND DEEP
This care report is submitted in partial fulfillment of the requirements of the degree of
Transitional Doctor of Physical Therapy (tDPT)
________________________________
Justin Bovee, MSPT
Approved: April, 2015
__________________________________
Rose M. Pignataro, PT, PhD, DPT, CWS
Committee chair/Advisor
The final copy of this case report has been examined by the signatories, and we find that both the content and the form meet acceptable presentation standards of scholarly work in the above mentioned discipline.
MIST ULTRASOUND HEALING OF WOUNDS
ACKNOWLEDGEMENTS
I would like to thank my advisor Dr. Rose Pignataro for providing the assistance,
expertise, and wisdom I needed to complete this scholarly paper. A special thank you goes to all
hospital staff at Lehigh Regional Medical Center for allowing me to utilize my skills in their
facility in order to complete this dissertation.
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MIST ULTRASOUND HEALING OF WOUNDS
TABLE OF CONTENTS
Abstract 2
Introduction 3
Methods 7
Results 14
Discussion 19
References 22
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MIST ULTRASOUND HEALING OF WOUNDS
ABSTRACT
OBJECTIVES: This case report examines the effectiveness of Mist Ultrasound Healing
Therapy® by Celleration, Inc. (Eden Prairie, MN) in promoting wound healing and selective
debridement for a deep tissue injury. The patient in this report is an 81 year old male presenting
with a necrotic deep tissue injury.
METHODS: This patient received Mist ultrasound, a non-contact, low frequency ultrasound (25
to 40 kHz) delivered to the wound bed via fine saline spray, while monitoring for signs of
healing. This intervention was given once daily for four consecutive days in the acute setting.
The treatment was discontinued due to the patient’s discharge to a skilled nursing facility for
short-term rehab. The Mist Therapy® was predicted to assist healing by reducing the area of
eschar in the patient’s wound and reducing the entire area of the wound bed. Additionally, greater
amounts of healing tissue or epithelialization would be supplanted. The wound is photographed
and measured daily before each treatment to help confirm that healing of the wound is taking
place.
RESULTS: The patient’s total wound area decreased from 14.06cm2 to 9.52cm2 and the area of
necrosis decreased from 1.0cm2 to 0.54cm2 after receiving Mist ultrasound.
DISCUSSION: Mist ultrasound shows promise toward achieving notable healing of deep tissue
injuries. The findings in this case report warrant further investigation of the effects of Mist
Therapy® on deep tissue injuries and other wound types.
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INTRODUCTION
Chronic wounds are sometimes called non-healing wounds. The rate of healing of these
wounds is not met within the anticipated time frame based on normal physiological processes.
According to Enoch & Leaper, full-thickness wounds are reduced up to 5-10% of its original size
in six weeks by contraction of a wound under normal physiological conditions1. Contraction and
epithelialization are secondary healing processes. However, some wounds are much slower to
heal. Months or even years may pass while persistent, non-healing wounds significantly impact a
person’s quality of life.2 Prognosis for healing is usually poor due to the long duration of the
wound. A wound that fails to respond to treatment during the first 2-4 weeks is also predicted to
have a poor healing prognosis.3 Chronic wound may be associated with diabetes, vascular
insufficiencies or ischemia, and deep tissue injuries. Chronic wounds are prevalent and difficult
to heal with increases health care costs to the patient. For instance, the most common cause of leg
ulcers in the Unites States is venous insufficiency. With these wounds, the standard of care does
not provide healing rates higher than 70%. Billions of dollars annually spent are spent in health
care cost for venous insufficiency ulcers alone.4 Nearly 15% of diabetic patients with develop a
foot ulcer in their lifetime; some of which do not heal.3 This makes them 30 to 40 times more at
risk of an amputation compared to non-diabetic patients.3,5 According to the manufacturer of the
Mist Therapy System, patients with persistent chronic wounds of various etiologies can benefit
from the accelerated healing this new modality provides.2 In general ultrasound has been widely
used for diagnostic and therapeutic purposes. It is the process of using mechanical energy in the
form of a sound or pressure wave at certain frequencies to provide these effects. Mist ultrasound
is a new and unique modality used for the treatment of wounds. The Mist Therapy® System from
Celleration®, Inc. is a non-contract and non-thermal ultrasound delivered through normal saline
solution as the medium. It is the only low-frequency ultrasonic modality approved by the FDA
for the purpose of treating wounds. It works by debriding the wound bed of devitalized tissue,
stimulating healthy cell growth and promoting angiogenesis, and removing bacteria.2,3
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MIST ULTRASOUND HEALING OF WOUNDS
Mist ultrasound uses a much lower frequency (25 kHz to 40 kHz) for debridement and
wound healing.6 This frequency is 40-75 times lower. It is still inaudible to the human ear
because it is outside the range of 20 Hz to 20 kHz.6 Intensity levels are also lower during MIST
ultrasound (0.1–0.8 W/cm2).4,7 These studies demonstrate that ultrasound shows promise for
wound healing but further investigation of the effectiveness Mist ultrasound is needed.
According to the manufacturer, the frequency and intensity of the sound waves from Mist
ultrasound are low enough that healthy cells and granulating tissue are undamaged. The sound
waves provide the energy to stimulate healthy growth from these cells while at the same time, kill
bacterial cells by targeting and fracturing the cell membrane. Bacterial cells are more susceptible
to micromechanical stress.2 Mist ultrasound’s impact on wound healing has been investigated via
the mechanism known as acoustical cavitation.3 This refers to the formation and oscillation of
microscopic bubbles that resonate with the frequency of the sound field. Acoustic energy is
concentrated in these bubbles causing cellular changes within the affected tissue.3 Moreover, this
effect is combined with microstreaming, which is the mechanism of sound waves that displace
ions and small molecules. Together, these processes can alter cell membrane activity.3,4
Changes in the synthesis and release of proteins within cells will occur along with increased
blood flow, vascular permeability, angiogenesis, and collagen formation and alignment.8
Although the benefits of ultrasound have been studied for nearly 50 years, Mist
ultrasound is a relatively new modality.5 In 2004, Thawer found a significant increase of blood
vessels and collagen formation in the granulation tissue of mice with experimental diabetes
mellitus after receiving ultrasound through a mist of saline solution.9 Similarly, Demir et al found
that ultrasound and laser treatment were both effective in promoting wound healing in
experimental lab rats. The laser treatment was provided via 904 nm wavelength, at 6 mW average
power, one Jcm2 dosage, 16 Hz frequency for a duration of 10 minutes.10 The ultrasound was
non-continuous and provided within a frequency range of 1 MHz to 3 MHz and at an intensity of
0.5 W/cm3. The ultrasound used in this study was not as effective as the laser treatment. The
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authors claimed this is due to the lack of thermal effects that provide the healing benefits in the
ultrasound, which were present in laser therapy.10 However, major differences between their use
of ultrasound and Mist ultrasound are noted. Firstly, Sterile Sonogel was used as a medium
instead of saline solution. Also, the frequency used in this study resembled that of traditional
ultrasound used such as in outpatient physical therapy clinics typically used to reduce pain and
inflammation (1 MHz to 3MHz).
Mist ultrasound has intrigued investigators to determine its effectiveness against a variety
of wound-related etiologies. Much of the more recent available literature investigates the effect of
Mist ultrasound on chronic wounds, diabetic foot ulcers, and vascular insufficiency ulcers. Some
researchers have used Mist Therapy as a stand-alone treatment and as a synergistic treatment to
investigate its effectiveness against chronic wounds of various etiologies.3,4 Although one study
was not a randomized control trial, both studies found that Mist ultrasound can be used as a stand-
alone intervention or in combination with other interventions. These studies emulate a similar
spectrum of cases that are seen in most wound care centers and represent a similar scope of
wound care practice that is applicable to a realistic clinical setting.3 However, authors will still
argue that there are a small number of studies that support the use Mist Ultrasound therapy for
treating wounds.
As stated before, chronic wounds have a poor prognosis for healing. Stand-alone
treatment methods may still be utilized, but wound healing may be expedited when used in
conjunction with Mist ultrasound. Most modalities in physical therapy are utilized as part of a
comprehensive program. This is also true in wound care and in the use of Mist Therapy where
there are multiple components of such as debridement types, topical agents, dressings, etc. that
work collectively within a patients wound-healing program. An observational study of a larger
sample size than the study by Ennis and colleagues also found that Mist ultrasound used in
combination with stand alone wound care promotes better wound healing in chronic wounds than
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standard wound care alone.5 The chronic wounds were also of various etiologies. Aside from
wound healing, Mist ultrasound is claimed to debride chronic wounds. However, there is not
sufficient evidence in the literature that Mist Therapy effectively debrides necrotic tissue from
wounds.6
Another small study examined the effect that non-contact ultrasound had on wound
closure, pain reduction, inflammation, and bacterial count of ten venous ulcers. A significant
reduction in wound area was found. There was an associated reduction of bacteria and cytokine
levels after receiving non-contact ultrasound, which supported the clinical use of Mist
ultrasound.11 Although the authors of this study credit the reduction of the wound area as
statistically significant after receiving Mist ultrasound, they explain that the reduction in bacteria
noted was not statistically significant.11
Other slow healing wounds are diabetes-related ulcers. Patients with diabetic ulcers are
30-40 times more likely to have an amputation than non-diabetic patients presenting with an
ulcer.3,8 A randomized, double-blind study was conducted in the hospital setting to determine the
safety and efficacy of Mist ultrasound for healing of diabetic foot ulcers and evaluate its effect on
wound closure and reduction of bacterial cultures. Ultrasound therapy significantly accelerated
healing times in recalcitrant diabetic foot wounds.8 The positive results found in this study
support Mist ultrasound as a safe and effective modality for accelerating healing in chronic
diabetic wounds.
Evidence is beginning to surface that MIST ultrasound is effective in treating wounds of
a variety of etiologies. Given the relatively small number of studies showing sufficient clinical
evidence and the scarcity of practice-based research in this area, there is a need for further study
regarding the application of the modality in direct patient care. Therefore, this case report will
examine the effectiveness of Mist ultrasound with normal saline solution in selective debridement
and/or acceleration of wound healing and granulation for partial thickness wounds, full thickness
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wounds, and deep tissue injuries. This study would focus on the development of a relatively new
and uncommon intervention that will deal with a persistent clinical problem among patients.
The patient in this study is an 81-year-old male admitted to the hospital for shortness of
breath. The patient presents with an unstageable and necrotic wound to the left hip over the
greater trochanter. Other findings upon the initial evaluation show that the patient exhibits several
factors increasing risk of delayed wound closure: he is mildly undernourished, confused with
dementia, and presents with general weakness with limited ability to transfer and ambulate.
Subjective findings include that the patient admits to sleeping on his left side a lot. The patient
also presents with a stage one pressure sore on the right medial knee. These findings suggest that
the patient’s wound on the left hip is the result of a deep tissue injury or pressure ulcer. In light of
his clinical presentation and presence of risk factors associated with delayed healing, this patient
is an excellent candidate for use of Mist Therapy®.
METHODS
Mist Therapy®, sometimes referred to Mist Ultrasound or non-contract ultrasound, is a
painless low frequency ultrasound delivered through normal saline solution as a mist to the
wound bed.7 The sound waves produced by this modality stimulate collagen and growth factor
production, leukocyte adhesion, and increase macrophage responsiveness to accelerate healing.7,8
Mist Therapy® is claimed to remove barriers to healing such as removing a wide-range of
bacteria, disrupt biofilm, reduce sustained inflammation, and reduce matrix metallopeptidase
(MMP-9).7 To stimulate cells to promote healing, Mist Therapy® increases blood flow through
vasodilation, increases angiogenesis, releases growth factors, and increases collagen deposition.7
These benefits are summarized in Table 1.
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Table 1. Summary of physiological effects as claimed by Mist Ultrasound Healing
Therapy® by Celleration, Inc. (Eden Prairie, MN)
Factors Impairing Healing Impact of MIST Therapy®
Impaired angiogenesis Stimulates angiogenesis
Deficient growth factors Causes upregulation of KGF, TGF-b1
Cellular Senescence Activates ERK and c-Jun n – Kinase