Sarah Medrano, RN, BSN, WOCN; and Mary Jo Beneke, RN, BS, CWOCN Yuma Regional Medical Center, Yuma, Arizona

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Sound Evidence coustic Pressure Wound Therapy to ebride Unstageable Pressure Ulcers in the cute Care Setting: Case Series Sarah Medrano, RN, BSN, WCN; and Mary Jo Beneke, RN, BS, CWCN Yuma Regional Medical Center, Yuma, rizona s of ctober 1, 2008, prompt identification and accurate staging of pressure ulcers present on admission to acute care hospitals became essential for Medicare reimbursement. In short, Medicare will no longer cover the added costs associated with care of Stage III and Stage IV pressure ulcers not present on admission; such ulcers will be classified as hospital-acquired conditions that could reasonably be prevented with application of evidence-based guidelines. Unstageable pressure ulcers present a particular challenge under the new policy. ccording to national pressure ulcer guidelines, until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined. The authors describe the first three patients (a 61-year-old woman and 52-year-old and 89-year-old men, all with different comorbidities and ulcer locations) to receive acoustic pressure wound therapy (PWT) for rapid debridement of unstageable pressure ulcers at their acute care hospital. Within 2 days, ulcers that had been completely covered with slough and/or eschar were cleared enough to be accurately identified as Stage III or Stage IV. Rapid and efficient debridement maximized reimbursement potential for the additional costs associated with these advanced-stage pressure ulcers. Key words: acoustic pressure wound therapy, pressure ulcers, wound care, acute care, debridement ccurate staging of pressure ulcers is important for proper diagnosis and treatment. 1 s of ctober 1, 2008, the prompt identification and accurate staging of pressure ulcers present on admission to acute care hospitals became essential for Medicare reimbursement ie, Medicare will no longer reimburse acute care hospitals at a higher rate for the increased costs of care associated with pressure ulcers that are not reported as present on admission or that deteriorate after admission. 2 ccording to MedPar 54 stomywound Management stomy Wound Management 2008;54(12):54 58 data 3 from January through September 2007, at $43,180 per hospital stay, care for the 257,412 cases of Stage III and Stage IV pressure ulcers treated cost the Medicare system $11 billion dollars. Certainly, efforts to reduce the occurrence and worsening of these potentially preventable and costly ulcers are warranted. These recent changes in reimbursement policy further challenge wound care clinicians in the acute care setting to promptly and accurately stage pressure ulcers classified as unstageable (ie, ulcers NT UPLICTE Support for Sound Evidence is provided by an educational grant from Celleration, Inc, Eden Prairie, Minn, to HMP Communications/stomy Wound Management. Celleration support to authors included medical writing and/or statistical support only; study design, patient selection, data collection, and metrics to measure wound healing are specific to the author. The opinions and statements herein are also specific to the author and are not necessarily those of Celleration, Inc., WM, or HMP Communications. Please note: these articles are subject to peer review. The opinions herein may not be consistent with the labeling for MIST Therapy Systems. Patients are selected for educational benefit. Visit www.celleration.com for the full package insert. Results may vary.

TE 54-58_WM1208_SoundEvidence:SoundEvidence.qxd 12/3/08 12:58 PM Page 55 B U PL IC C T Figure 1. Sacral pressure ulcer in Patient 1 is unstageable before PWT (); Stage IV with exposed bone after two PWT treatments over 2 days (B). Pressure ulcer of the left lateral ankle in Patient 2 is unstageable before PWT (C); Stage III with progress toward healing after 5 days of PWT (). N with substantial slough and/or eschar that obscures the true depth of the wound). In staging pressure ulcers, the key determinant for Stage III or Stage IV classification is depth of tissue damage.1 The National Pressure Ulcer dvisory Panel (NPUP)1 guidelines for pressure ulcer staging are clear: until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined. Ulcers classified unstageable on admission could present a particular problem in acute care hospitals, where Stage III and Stage IV pressure ulcers not present on admission are considered by Medicare to be hospital-acquired conditions that could reasonably have been prevented through the application of evidence-based guidelines.2 If unstageable ulcers are later classified as Stage III or Stage IV after debridement has exposed true wound depth, they are considered hospital-acquired because they were not present on admission, and the added costs of care for these Stage III or Stage IV ulcers would not be eligible for reimbursement.2 Therefore, the new policy puts a premium on rapid and efficient debridement of unstageable pressure ulcers in order to identify Stage III and Stage IV ulcers present on admission and allow for Medicare reimbursement of the added costs associated with care of these advanced-stage ulcers. Wound care clinicians have a range of debridement options, including sharp or surgical, mechanical, enzymatic, and autolytic.4 Ultrasound therapies such as acoustic pressure wound therapy (PWT) are typically classified as mechanical. This case series describes the authors experience using PWT to help remove necrotic tissue from ecember 2008 Vol. 54 Issue 12 55

Patient/Wound Patient 1: 89-year-old man Bedridden, history of pressure ulcers, diabetes, myocardial infarction, dementia Location: sacrum Patient 2: 52-year-old man iabetes, hypertension, chronic pain syndrome, chronic morphine use, smoker Location: left lateral ankle Patient 3: 61-year-old woman Breast cancer with metastasis to lung, not tolerating chemotherapy, radiation, hypertension Location: left heel unstageable pressure ulcers in an effort to expeditiously expose the wound base and stage pressure ulcers accurately on admission to an acute care facility. Case Series TBLE 1 UNSTGEBLE PRESSURE ULCERS PRESENT N HSPITL MISSIN EBRIE WITH PWT uration of PWT 2 days 7 min/day 2 days a 3 min/day 2 days 4 min/day The authors began using PWT (MIST Therapy System, Celleration Inc., Eden Prairie, Minn.) at their acute care hospital on a trial basis in September 2008. The patients reported here are the first three patients for which the authors were consulted to evaluate unstageable pressure ulcers and the only three such cases during the 1-month trial period. Pressure ulcer was the primary reason for hospitalization of Patient 1 and a secondary diagnosis for Patients 2 and 3. PWT was utilized to assist with debridement of slough and eschar in the wound beds of pressure ulcers unstageable on admission. Before utilizing PWT for debridement of unstageable pressure ulcers at this facility, such wounds were treated with sharp or enzymatic Tissue Characteristics Pre-PWT Post-PWT 100% adherent 30% slough grey slough 70% granulation 50% eschar 40% slough 10% unhealthy pink 100% tan/brown thick slough 50% slough 50% granulation 80% yellow slough 20% granulation Pressure Ulcer Stage Pre-PWT Post-PWT Unstageable Stage IV exposed bone Note: Sharp debridement performed pre and post PWT; substantially more slough was removed after PWT Unstageable Unstageable Stage III Stage IV Necrotic tissue continued to obscure the wound bed after application of papain urea. b fter PWT, red tissue down to muscle was visible a lthough the wound was stageable after 2 days, PWT was continued for 3 more days to promote healing before discharge. b The US Food and rug dministration has since issued a statement that topical papain urea products have not been proven safe or effective and are therefore considered unapproved products. debridement and moist wound healing. PWT was administered as an adjunct to moist and enzymatic wound dressings, including collagenase and gauze (Patient 1), petrolatum gauze with bismuth tribromophenate followed by hydrocolloids (Patient 2), and papain urea (Patient 3; see footnote to Table 1). s shown in Table 1, all three wound beds were covered completely with slough and eschar, eliminating the possibility of accurately staging the wounds based on depth of tissue damage. Sufficient debridement to enable accurate staging of all wounds as Stage III or Stage IV was achieved in 2 days. Wound area remained unchanged in Patient 1 (16 cm 2 ) and Patient 3 (8.75 cm 2 ) after 2 days of PWT, but decreased by more than 50% in Patient 2 (1.95 cm 2 to 0.88 cm 2 ) after 5 days of PWT (see Figure 1). Patients were discharged home within 1 day of the last PWT treatment (Patients 1 and 2 same day, Patient 3 next day) with either hospice staff or family members performing dressing changes. NT UPLICTE 56 stomywound Management

iscussion With the recent change in Medicare reimbursement policy for pressure ulcers, debridement that facilitates accurate pressure ulcer stage on admission in the acute care setting has become a priority. In these three patients, using PWT to assist with debridement of unstageable pressure ulcers allowed for staging of the wounds as Stage III and Stage IV within 2 days of admission, which should maximize the MS/RG and potential for reimbursement appropriate to the severity of these wounds. In their Guidelines for the Treatment of Pressure Ulcers, the Wound Healing Society 4 lists several debridement modalities, including sharp or surgical, mechanical, enzymatic, and autolytic. Based on a review of the evidence and expert consensus, these guidelines describe the following benefits and drawbacks to these debridement methods. Surgical/sharp debridement is indicated for fast and effective removal of large amounts of necrotic tissue. However, these techniques require significant expertise, adequate vascular supply to the wound, and systemic antibacterial coverage in cases of systemic sepsis. dditionally, sharp debridement is contraindicated in patients with bleeding disorders or on anticoagulation therapy. Finally, the pain associated with surgical/sharp debridement often requires narcotic pain medication and can be intolerable despite use of narcotic agents. 4 Mechanical debridement (using wet-to-dry dressings, wound irrigation, and whirlpool techniques) physically removes necrotic tissue. lthough effective in some cases, such strategies also have their drawbacks. Wet-to-dry dressings can be painful and may damage viable newly formed tissue. High- or low pressure streams or pulsed lavage can cause trauma to the wound bed as well as pain for the patient. Whirlpools may be helpful initially to loosen and remove debris and necrotic tissue but are associated with risk of tissue maceration and bacterial contamination. 4 Using dressings with endogenous (autolytic debridement) or exogenous enzymes (enzymatic debridement) to soften and remove necrotic tissue can take up to 2 weeks or more. Furthermore, this method is not recommended for infected wounds or very deep wounds that require packing. 4 To date, the only known contraindications for use of PWT are those common to other ultrasound therapies ie, areas near electronic implants/prostheses, on the lower back during pregnancy or over a pregnant uterus, and over areas of malignancy must be avoided. 5 lthough a range of biophysical effects of PWT on the wound healing process have been described in a recent literature review by Unger 6 (eg, activation of inflammatory cells and fibroblasts; promotion of collagen synthesis, cell division, angiogenesis, and growth factors; and inhibition of matrix metalloproteinase activity), PWT qualifies as a debridement option owing to its indication for removal of yellow slough, fibrin, tissue exudates, and bacteria. 5 However, clinical studies to date have not evaluated PWT specifically as a debridement modality. Rather, the randomized and nonrandomized studies have shown a benefit of adjuvant PWT (primarily in lower-extremity ulcers) on healing outcomes, such as proportion of wounds healed, volume reduction, and healing rate, relative to conventional wound therapies alone. 7-11 Conclusion Ultimately, the recent change in Medicare reimbursement policy with regard to pressure ulcer care has put a premium on the rapidity with which acute care clinicians establish the stage of pressure ulcers, including ulcers unstageable on admission. This report of an early experience using PWT to expedite slough/eschar removal and allow for accurate staging of pressure ulcers suggests that PWT may be a clinically useful tool for acute care wound clinicians. Further research into the fastest, most efficient ways to clear necrotic tissue from unstageable pressure ulcers would be of particular value to wound care clinicians in the acute care setting. - WM References NT UPLICTE 1. Black J, Baharestani M, Cuddigan J, et al. National Pressure Ulcer dvisory Panel s updated pressure ulcer staging system. Urol Nurs. 2007;27(2):144 156. 2. Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates. Federal Register. Part II. Vol 72: Center for Medicare and Medicaid Services; 2007:47200 47201. ecember 2008 Vol. 54 Issue 12 57

54-58_WM1208_SoundEvidence:SoundEvidence.qxd 12/3/08 12:58 PM Page 58 IC TE 8. Ennis WJ, Valdes W, Gainer M, Meneses P. Evaluation of clinical effectiveness of MIST ultrasound therapy for the healing of chronic wounds. dv Skin Wound Care. 2006;19(8):437 446. 9. Kavros SJ, Liedl, Boon J, Miller JL, Hobbs J, ndrews KL. Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. dv Skin Wound Care. 2008;21(9):416 423. 10. Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004 2006. dv Skin Wound Care. 2007;20(4):221 226. 11. Kavros SJ, Schenck EC. Use of noncontact low-frequency ultrasound in the treatment of chronic foot and leg ulcerations: a 51-patient analysis. J m Podiatr Med ssoc. 2007;97(2):95 101. N T U PL 3. Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates. Federal Register. Part II. Vol 73: Center for Medicare and Medicaid Services; 2008:48471 48474. 4. Whitney J, Phillips L, slam R, et al. Guidelines for the treatment of pressure ulcers. Wound Repair Regen. 2006;14(6):663 679. 5. MIST Therapy System Instructions for Use. Eden Prairie, Minnesota: Celleration, Inc.; 2006. 6. Unger PG. Low-frequency, noncontact, nonthermal ultrasound therapy: a review of the literature. stomy Wound Manage. 2008;54(1):57 60. 7. Ennis WJ, Foremann P, Mozen N, Massey J, ConnerKerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. stomy Wound Manage. 2005;51(8):24 39. 58 stomywound Management