MIST ULTRASOUND HEALING OF WOUNDS

Transcription

1 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

2 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.

3 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.

4 TABLE OF CONTENTS 1 Abstract 2 Introduction 3 Methods 7 Results 14 Discussion 19 References 22

5 ABSTRACT 2 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 14.06cm 2 to 9.52cm 2 and the area of necrosis decreased from 1.0cm 2 to 0.54cm 2 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.

6 INTRODUCTION 3 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 conditions 1. 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

7 Mist ultrasound uses a much lower frequency (25 khz to 40 khz) for debridement and 4 wound healing. 6 This frequency is 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 ( W/cm 2 ). 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 Jcm 2 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/cm 3. The ultrasound used in this study was not as effective as the laser treatment. The

8 authors claimed this is due to the lack of thermal effects that provide the healing benefits in the 5 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 standalone 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

9 standard wound care alone. 5 The chronic wounds were also of various etiologies. Aside from 6 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 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

10 7 MIST ULTRASOUND HEALING OF WOUNDS 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.

11 Table 1. Summary of physiological effects as claimed by Mist Ultrasound Healing Therapy by Celleration, Inc. (Eden Prairie, MN) 8 Factors Impairing Healing Impaired angiogenesis Deficient growth factors Cellular Senescence Bacterial bioburden Bacterial infection Pain Impact of MIST Therapy Stimulates angiogenesis Causes upregulation of KGF, TGF-b1 Activates ERK and c-jun n Kinase Removes biofilm Decreases bacteria (VRE, MRSA, Pseudomonas 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.

12 9 Figure 1: Mist Ultrasound Healing Therapy by Celleration, Inc. (Eden Prairie, MN) Photo of generator and transducer from 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 retrieved April 15, 2015

13 Table 2. Application MIST Therapy 1. Clinicians hands and transducer are cleansed. 10 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 (cm 2 ) 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.

14 Table 3. Contraindications to using MIST Therapy 11 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 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

15 staff continually round on the patient and reinforce the importance of offloading the left hip 12 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 < 4cm to 16 cm to 36 cm to 80 cm 2 5. Area > 80 cm 2 2. Depth 1. Non-blanchable erythema on intact skin 4 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 3. Edges 1. Indistinct, diffuse, none clearly visible 2 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 4. Undermining 1. Less than 2 cm in any area 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 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 6. Necrotic Tissue Amount 5. Firmly adherent soft, black eschar 1. None visible 2. < 25% of wound bed covered % to 50% of wound covered 4. 4 > 50% and <75% of wound covered 5. 75% to 100% of wound covered 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 4 1

16 13 Table 4 Continued from previous page ITEM ASSESSMENT SCORE 8. Exudate Amount 1. None, dry wound 2 2. Scant, wound moist but no observable exudate 3. Small 4. Moderate 5. Large 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 Peripheral Tissue Edema 1. minimal swelling around wound 1 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 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 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 13. Epithelialization % 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 TOTAL SCORE 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

17 measures 3.4cm x 3.2cm with the necrotic eschar measuring 1cm 2. The patient also continues 14 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 (14.06cm 2 ) on Day 1 and 3.4cm x 2.8cm (9.52cm 2 ) 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

18 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) ITEM ASSESSMENT SCORE 1. Size 1. Area < 4cm to 16 cm to 36 cm to 80 cm 2 5. Area > 80 cm 2 2. Depth 1. Non-blanchable erythema on intact skin 4 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 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 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 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 4 6. Necrotic Tissue Amount 5. Firmly adherent soft, black eschar 1. None visible 2. < 25% of wound bed covered % to 50% of wound covered 4. 4 > 50% and <75% of wound covered 5. 75% to 100% of wound covered 7. Exudate Type 1. None 2. Bloody 3. Serosangiunous, thin, watery, pale red/ pink 4. Serous: thin, watery, clear 8. Exudate Amount 9. Skin Color Surrounding Wound 5. Purulent: thin or thick, opaque, tan/ yellow, with or without color 1. None, dry wound 2. Scant, wound moist but no observable exudate 3. Small 4. Moderate 5. Large 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 Table 5 Continued on Next Page

19 16 Table 5 Continued from previous page ITEM ASSESSMENT SCORE 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 Peripheral Tissue Induration 12. Granulation Tissue 13. Epithelializatio n 5. Crepitus and/ or pitting edema extends 4 cm around wound 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. 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 % 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 TOTAL SCORE Total Wound Area Wound Area (cm2) 2 0 Day 1 Day 2 Day 3 Day 4 Figure 3. Total Wound Area

20 Area of Eschar only (cm) Eschar area (cm2) Day 2 Day 3 Day 4 Figure 4. Area of Eschar Figure 5. Photo left hip

21 18 Figure 6. Photo left hip Figure 7. Photo left hip

22 19 Figure 8. Photo left hip 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

23 20 MIST ULTRASOUND HEALING OF WOUNDS 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

24 21 MIST ULTRASOUND HEALING OF WOUNDS 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.

25 REFERENCES Enoch S, Leaper DJ. Basic Science of Wounds Healing. Surgery. 2005: 23(2): Celleration Inc. MIST ultrasound healing therapy. Mist Therapy Website. Updated Accessed June 14, Ennis W, Valdes W, Gainer M, Meneses P. Evaluation of clinical effectiveness of Mist ultrasound therapy for the healing of chronic wounds. Advances in Skin and Wound Care. 2005; 10(8): Escandon J, Vivas AC, Perez R, Kirsner R, Davis S. A prospective pilot study of ultrasound therapy effectivenss in refractory venous leg ulcers. International Wound Journal. 2012; 9: Kavros S, Liedl D, Boon A, Miller J, Hobbs J, Andrews K. Expedited wound healing with noncontact low-frequency ultrasound therapy in chronic wounds: A retrospective analysis. Advances in Skin & Wound Care. 2008; 21(9): Ramundo J, Gray M. Is ultrasonic mist therapy effective for debriding chronic wounds? J Wound Ostomy Continence and Nursing. 2008; 35(6): Kent, D. Getting misty over wound care: Learn how therapy with ultrasound waves and saline mist can help your patient s wound heal. Nursing. 2007; 37(9): Ennis W, Formann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy/Wound Management. 2005; 51(8): Thawer H. Effects of ultrasound delivered through a mist of saline to wounds in mice with diabetes mellitus. J Wound Care. 2004; 13(5): Demir H, Yaray S, Kirnap M, Yaray K. Comparison of the effects of laser and ultrasound treatment on experimental wound healing in rats. J Rehab Research and Development. 2004; 41(5): Kavros S, Miller J, Hanna S. Treatment of ischemic wounds with noncontact, lowfrequency ultrasound: The Mayo Clinic Experience, Advances in Skin & Wound Care. 2007; 20(4): Sussman C, Bates-Jensen B. A Collaborative Practice Manual for Health Professions 3 rd edition. Baltimore, MD & Philadelphia, PA Lippincott Williams & Wilkins Attinger C, Janis J, Steinberg J, Schwartz J, Al-Attar A, & Couch K. Clinical Approach to Wounds: Debridement and Wound Bed Preparation Including the Use of Dressings and Wound-Healing Adjuvants. Plastic and Reconstructive Surgery. 2006: 117(Suppl), 72S-109S.