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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


APPROVAL SHEET

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.


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.

1


TABLE OF CONTENTS

Abstract 2

Introduction 3

Methods 7

Results 14

Discussion 19

References 22

2


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.

3


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

4


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

5


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

6


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

7


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.

8


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

Bacterial bioburden Removes biofilm

Bacterial infection Decreases bacteria (VRE, MRSA,

Pseudomonas

Pain Modulates pain

The Mist Therapy® product consists of the ultrasound generator, which creates sound

waves that are sent from the transducer tip to the wound bed. The transducer is also called “the

wand” which is held near the wound bed. The metal tip of the transducer vibrates over 40,000

times per second to produce sound waves at 25,000Hz to 40,000Hz without direct contact.7 The

applicator is a disposable piece of plastic that fits over the transducer. It holds and punctures the

saline bottle, which is congruently fit. The saline becomes the conduit for the sound waves to the

sound bed. The saline and applicator must be discarded after each treatment for infection control.

They are single use only. Table 2 explains in detail how the Mist Therapy® system is applied.

Contraindications to use of the Mist Therapy® system are summarized in Table 3.

9


Figure 1: Mist Ultrasound Healing Therapy® by Celleration, Inc. (Eden Prairie, MN) Photo of

generator and transducer from http://misttherapy.com retrieved April 15, 2015

Figure 2. Mist Ultrasound Healing Therapy® by Celleration, Inc. (Eden Prairie, MN) Photo of

application, saline bottle, and Super Sani-Cloths from http://misttherapy.com retrieved April 15,

2015

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Table 2. Application MIST Therapy®

1. Clinicians hands and transducer are

cleansed.

Hand hygiene and disinfecting the

transducer, cable, and entire generator

unit is required for infection control.

2. Machine is plugged in and turned on -

3. Infection control personal protective

equipment

Clean gloves, gown, hair net, and face

shield are donned prior to application.

4. Indicate wound size Wound area (cm2) is selected on

generator. The generator calculates the

duration of treatment based on the

selected area.

The disposable absorbent pad provided

in the Mist Therapy® Kit beneath

wound to collect saline and wound

exudate.

5. Applicator cup is attached The applicator is attached to the

transducer until an audible ‘click’ is

heard. The bottle of saline provided in

the kit is inserted into the applicator to

allow a puncture into bottom of the

saline bottle. The bottle and the

applicator are turned 90 degrees

counter-clockwise to align the

applicator opening.

6. Vent opened The cap of the saline bottle is twisted

off.

7. Positioning of the transducer tip The transducer tip is perpendicular to

the wound and 0.5 to 1.5 cm away

while ultrasound is being delivered

through the saline medium. Slow

circular motions over the wound bed

are employed until treatment is over.

The generator will automatically stop

when the given treatment is over.

8. Machine is turned off The applicator is turned 90 degrees

clockwise to stop the saline flow. The

applicator and saline bottle and

discard. The entire Mist ultrasound

unit is cleansed.

11


Table 3. Contraindications to using MIST Therapy®

Usage over electronic implants or prostheses (i.e.: pacemaker). The ultrasound may

disrupt the function of these devices

Usage over the lower back or uterus of a pregnant patient.

Usage over areas of malignancy, which may stimulate cell growth.

The initial evaluation is completed on day 1 using the Bates-Jensen Wound Assessment

Tool (BWAT), formerly known as the Pressure Sore Status Tool (PSST). This assessment tool

has been shown to demonstrate acceptable reliability and validity. Among clinicians with special

wound management training, this model has yielded an inter-rater reliability coefficient of 0.91

and an intra-rater reliability of 0.975. Clinicians who did not have extraordinary wound

management experience yielded an intra-rater reliability of 0.89 while a reliability estimate of

0.82 was calculated for the inexperienced practitioners versus the expert clinicians. The average

overall content validity index measured 0.91 at the p = .05 level.12

The patient’s wound measuring 3.8cm x 3.7cm is located on the left hip over the greater

trochanter. The wound is unstageable secondary to being 100% covered with hard black eschar.

Detail of the patient’s wound upon evaluation is provided table 4. The evaluation assesses many

characteristics of the wound and scores each category. The total score is set as a baseline.

Upon each treatment including the initial evaluation, Mist Therapy® is applied to the left

hip for four minutes then patted dry with sterile absorbent pads. A 2in x 2in Silverlon® contact

dressing and a hydrocolloid dressing are applied to the left hip. The patient also receives physical

therapy for strengthening and balance training to improve safe transferring and ambulation to

ensure the patient has enough functional independence to frequently offload pressure while

resting in a bed or chair. Moderate assist is required to complete supine to sit. The patient is

ambulatory up to 160 feet total with a front-wheeled walker and contact-guard assist. Nursing

12


staff continually round on the patient and reinforce the importance of offloading the left hip

throughout the entire hospital admission. Since the patient is not resting on an air mattress,

assistance for positioning is provided by the nursing staff by unilaterally offloading one hip with

a pillow and alternating every two hours.

TABLE 4: Day 1 – Initial Evaluation Using the Bates-Jensen Wound Assessment Tool (BWAT)

ITEM ASSESSMENT SCORE

1. Size 1. Area < 4cm2

2. 4 to 16 cm2

3. 16.1 to 36 cm2

4. 4. 36.1 to 80 cm2

5. Area > 80 cm2

2

2. Depth 1. Non-blanchable erythema on intact skin

2. Partial thickness involving loss of epidermis and/ or dermis

3. Full thickness skin loss involving damage or necrosis of subcutaneous

tissue

4. Obscured by necrosis

5. Full thickness skin loss with extensive destruction, tissue necrosis, or

damage to muscle, bone or supporting structures

4

3. Edges 1. Indistinct, diffuse, none clearly visible

2. Distinct, outline clearly visible, attached, even with wound base

3. Well-defined, not attached to wound base

4. Well-defined, not attached to wound base, rolled under, thickened

5. Well-defined, fibrotic, scarred or hyperkeratotic

2

4. Undermining 1. Less than 2 cm in any area

2. 2 to 4 cm involving > 50% of wound margins

3. 2 to 4 cm involving <50% of wound margins

4. More than 4 cm in any area

5. Tunneling and/ or sinus tract formation

1

5. Necrotic

Tissue Type

1. Non visible

2. White/gray non-viable tissue and/ or non-adherent yellow

3. Loosely adherent yellow slough

4. Adherent soft, black eschar

5. Firmly adherent soft, black eschar

5

6. Necrotic

Tissue

Amount

1. None visible

2. < 25% of wound bed covered

3. 3. 25% to 50% of wound covered

4. 4 > 50% and <75% of wound covered

5. 75% to 100% of wound covered

4

7. Exudate Type 1. None

2. Bloody

3. Serosangiunous, thin, watery, pale red/ pink

4. Serous: thin, watery, clear

5. Purulent: thin or thick, opaque, tan/ yellow, with or without color

1

13


Table 4 Continued from previous page


8. Exudate Amount 1. None, dry wound

2. Scant, wound moist but no observable exudate

3. Small

4. Moderate

5. Large

2

9. Skin Color Surrounding

Wound

1. Pink or normal for ethnic group

2. Bright red and/ or blanches to touch

3. White or gray pallor or hypopigmented

4. Dark red or purple and non-blanchable

5. Black or hyperpigmented

2

10. Peripheral Tissue Edema 1. minimal swelling around wound

2. non-pitting edema extends < 4 cm around wound

3. non-pitting edema extends ≥ 4 cm around wound

4. Pitting edema extends < 4 cm around wound

Crepitus and/ or pitting edema extends ≥ 4 cm around

wound

1

11. Peripheral Tissue

Induration

1. Minimal firmness around wound

2. Induration less than 2 cm around wound

3. Induration 2 to 4 cm extending < 50% around wound

4. Induration 2 to 4 cm extending ≥ 50% around wound

Induration > 4 cm in any area

5

12. Granulation Tissue 1. Skin intact or partial thickness wound

2. Bright, beefy red: 75% to 100% of wound filled and/ or

tissue overgrowth

3. Bright, beefy re: < 75% and > 25% of wound filled

4. Pink and/ or dull, dusky red and/ or fills < 25% around

wound

No granulation tissue present

5

13. Epithelialization 1. 100% of wound covered, surface intact

2. 75% to < 100% of wound covered and/ or epithelial tissue

extends more than 0.5 cm into wound bed

3. 50% to <75% of wound covered and/ or epithelial tissue

extends to less than 0.5 cm into wound bed

4. 25% to <50% wound covered

<25% wound covered

4

TOTAL SCORE 34

On Day 2, the Mist ultrasound is repeated and the same dressings are applied. The wound

area measured 3.4cm x 3.2cm with a paper ruler and presented and significantly less black

necrotic tissue noted, measuring 1.6cm x 1.2cm in area. Whitish-yellow, loosely-adherent slough

is present covering the area of the wound that previously was covered with eschar, which

collectively still encompass 100% of the wound surface total.

A reassessment is completed on Day 3 and the Mist ultrasound and dressing changes are

repeated. Table 5 summarizes the full reassessment of the wound. On this day the wound

14


measures 3.4cm x 3.2cm with the necrotic eschar measuring 1cm2. The patient also continues

physical therapy once daily beginning immediately after every Mist ultrasound session. The

patient is making slow progress with physical therapy from a functional mobility standpoint.

Minimal assist is required for transfers and bed mobility. The patient’s ambulation distance only

increased by 20 additional feet and still requires a walker for balance. Day 4 is the day of the

patient’s discharge from the hospital to a skilled nursing facility for short-term rehab. A final

treatment of Mist ultrasound with dressing changes is completed. The wound now measures

3.4cm x 2.8cm with the eschar measuring 0.9cm x 0.6cm. In the skilled nursing facility, the

patient will no longer receive Mist Ultrasound Therapy® as it is not provided in the particular

facility. However, the patient will have regular hydrocolloid dressing changes completed by the

wound care nurse as ordered in the hospitalist’s discharge instruction.

RESULTS

Table 5 summarizes the reassessment of the wound, which was completed on Day 3 (the

day prior to the patient’s discharge and final treatment). The total score of 34 upon Day 1 and the

evaluation has reduced to 32 upon the reassessment on Day 3. A lower number in this case

indicates progression in wound healing. The patient’s wound measured 3.8cm x 3.7cm

(14.06cm2) on Day 1 and 3.4cm x 2.8cm (9.52cm2) on Day 4, which is a 32% reduction in size in

just three days. According to Attinger et al, the normal rate of healing shows 10-15% reduction in

wound dimensions one week.13 The patient’s wound in this report shows accelerated healing,

demonstrating potential for Mist ultrasound to promote restoration of normal wound healing

rates. Steady decreases in total wound bed area and eschar are illustrated in figure 3 and figure 4

respectively. The patient’s deep tissue injury showed overall improvement and healing while

receiving Mist Therapy® combined with dressing changes, physical therapy, and monitoring by

the nursing staff and other clinical staff in the acute care setting. Figures 5-8 are photos of the

patient’s left hip. One photo is taken upon each visit (Day 1-4) to illustrate the characteristic

15


changes that have been noted on a daily basis. The photos are kept as part of the patient’s chart in

the acute setting for documentation.

TABLE 5: Day 1 – Initial Evaluation Using the Bates-Jensen Wound Assessment Tool (BWAT)


1. Size 1. Area < 4cm2

2. 4 to 16 cm2

3. 16.1 to 36 cm2

4. 4. 36.1 to 80 cm2

5. Area > 80 cm2

2

2. Depth 1. Non-blanchable erythema on intact skin

2. Partial thickness involving loss of epidermis and/ or dermis

3. Full thickness skin loss involving damage or necrosis of subcutaneous

tissue

4. Obscured by necrosis

5. Full thickness skin loss with extensive destruction, tissue necrosis, or

damage to muscle, bone or supporting structures

4

3. Edges 1. Indistinct, diffuse, none clearly visible

2. Distinct, outline clearly visible, attached, even with wound base

3. Well-defined, not attached to wound base

4. Well-defined, not attached to wound base, rolled under, thickened

5. Well-defined, fibrotic, scarred or hyperkeratotic

2

4. Undermining 1. Less than 2 cm in any area

2. 2 to 4 cm involving > 50% of wound margins

3. 2 to 4 cm involving <50% of wound margins

4. More than 4 cm in any area

5. Tunneling and/ or sinus tract formation

1

5. Necrotic

Tissue Type

1. Non visible

2. White/gray non-viable tissue and/ or non-adherent yellow

3. Loosely adherent yellow slough

4. Adherent soft, black eschar

5. Firmly adherent soft, black eschar

4

6. Necrotic

Tissue

Amount

1. None visible

2. < 25% of wound bed covered

3. 3. 25% to 50% of wound covered

4. 4 > 50% and <75% of wound covered

5. 75% to 100% of wound covered

4

7. Exudate Type 1. None

2. Bloody

3. Serosangiunous, thin, watery, pale red/ pink

4. Serous: thin, watery, clear

5. Purulent: thin or thick, opaque, tan/ yellow, with or without color

1

8. Exudate

Amount

1. None, dry wound

2. Scant, wound moist but no observable exudate

3. Small

4. Moderate

5. Large

2

9. Skin Color

Surrounding

Wound

1. Pink or normal for ethnic group

2. Bright red and/ or blanches to touch

3. White or gray pallor or hypopigmented

4. Dark red or purple and non-blanchable

5. Black or hyperpigmented

2

Table 5 Continued on Next Page

16


Table 5 Continued from previous page


10. Peripheral

Tissue Edema

1. minimal swelling around wound

2. non-pitting edema extends < 4 cm around wound

3. non-pitting edema extends ≥ 4 cm around wound

4. Pitting edema extends < 4 cm around wound

5. Crepitus and/ or pitting edema extends ≥ 4 cm around wound

1

11. Peripheral

Tissue

Induration

1. Minimal firmness around wound

2. Induration less than 2 cm around wound

3. Induration 2 to 4 cm extending < 50% around wound

4. Induration 2 to 4 cm extending ≥ 50% around wound

5. Induration > 4 cm in any area

1

12. Granulation

Tissue

1. Skin intact or partial thickness wound

2. Bright, beefy red: 75% to 100% of wound filled and/ or tissue

overgrowth

3. Bright, beefy re: < 75% and > 25% of wound filled

4. Pink and/ or dull, dusky red and/ or fills < 25% around wound

5. No granulation tissue present

4

13. Epithelializatio

n

1. 100% of wound covered, surface intact

2. 75% to < 100% of wound covered and/ or epithelial tissue extends

more than 0.5 cm into wound bed

3. 50% to <75% of wound covered and/ or epithelial tissue extends to

less than 0.5 cm into wound bed

4. 25% to <50% wound covered

5. <25% wound covered

4

TOTAL SCORE 32

0

2

4

6

8

10

12

14

16

Day 1 Day 2 Day 3 Day 4

Total Wound Area

Wound Area (cm2)

Figure 3. Total Wound Area

17


0

0.5

1

1.5

2

2.5

Day 2 Day 3 Day 4

Area of Eschar only (cm)

Eschar area (cm2)

Figure 4. Area of Eschar

Figure 5. Photo left hip 11-04-2014

18




19


DISCUSSION

The effectiveness of Mist ultrasound has been investigated mostly within the past 10

years. Investigators used non-contact ultrasound on mice and rats with experimental diabetic

wounds. More research on Mist ultrasound began surfacing but with small subject size designs.

Very limited randomized control trials were utilized. Also, some research that is available comes

from the machine’s manufacturer, which may facilitate potential research bias. Some research

found Mist ultrasound to be helpful in treating wounds while other sources indicate that there is

no significant evidence to support that Mist ultrasound is effective in debriding wounds.

Therefore the already limited research sometimes presents conflicting results and conclusions.

This may be due to some studies utilizing small sample sizes and suboptimal intervention

designs. The purpose of this case report is to illustrate how Mist ultrasound can be utilized in

wound care to treat deep tissue injuries by performing selective debridement and promoting

wound healing. Mist ultrasound is overall very time-efficient, easy to apply, and has very limited


20


contraindications for use. Patient non-compliance issues with Mist Ultrasound may be less likely

since this modality is painless. Clinical use requires an order under a physician and may feasibly

be used in many appropriate acute, sub-acute, and outpatient clinics that are subject to treating a

variety of wounds, whether chronic or acute.

Chronic wounds are difficult to heal. Yet that is why they are chronic in nature.

Oftentimes co morbidities are present such as diabetes mellitus and peripheral vascular disease.

Mist Ultrasound is a new modality that has been acquiring more and more attention in the past ten

years to assist healing in chronic wounds. The purpose of this case report is to examine the effects

Mist Ultrasound has on a slow healing wound. The findings in this case report would contribute

to the limited literature that exists regarding the effects of Mist Ultrasound in non-healing

wounds. Early literature found that ultrasound delivered through normal saline could increase

collagen formation and granulation tissue within wounds among mice and lab rats.9,10 In the

patient population, Mist Ultrasound has been used on chronic wounds, diabetic ulcers, vascular

insufficiency ulcers and has been shown to be effective even as a stand alone treatment for

wounds.3,4 Advocates of MIST ultrasound claim that this modality targets free radicals and

bacteria and eliminates them via the ultrasound. Despite this, some studies have not found a

statistically significant reduction in bacteria of chronic wounds although some bacterial reduction

was noted.4

The patient in this study received Mist Therapy® one time daily for four consecutive

days to treat a necrotic deep tissue injury on the left hip over the greater trochanter. Over the

course of those four days, the patient’s wound showed decreasing total area and black eschar.

The patient was also given pressure relief from the left greater trochanter by the RN staff via

proper positioning and offloading of the left hip. Daily physical therapy assisted in regaining the

patients overall functional mobility and independence. Various absorbent dressings were changed

at least once daily and following each Mist Therapy® treatment to ensure protection of healthy

21


tissue and absorption of drainage from the wound. The patient presented with scant to no drainage

upon each visit by physical therapy staff.

Without the use of sharp debridement, most of the necrosis of the wound progressed from

hard, black eschar to soft, loosely adherent whitish-yellow slough. Sharp debridement is

alternative form of wound care that is painful compared to Mist Therapy®, results in increased

bleeding, and requires a skill level that is more laborious to the clinician. For instance, sharp

debridement requires higher use of fine motor control and careful, precise hand movement.

Pulsed-lavage is also a more painful alternate to wound care than Mist Therapy®.

Overall, the patient displayed remarkable progress in acceleration of debridement of

necrotic tissue and reduction in wound size over the course of only four daily treatments using

Mist therapy as an adjunct to conventional treatment. Mist Therapy® shows promise toward

achieving notable healing of deep tissue injuries and possibly other wound types. This case study

suggests that additional research is warranted while employing and a more controlled

environment to further investigate the effects of Mist Therapy® on deep tissue injuries and other

wound types.

22


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4. Escandon J, Vivas AC, Perez R, Kirsner R, Davis S. A prospective pilot study of

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