Patient-Centric Wound Care: Case-Based Journeys with Leading-Edge Modalities

Transcription

1 Patient-Centric Wound Care: Case-Based Journeys with Leading-Edge Modalities Christopher L. Barrett, DPM, CWS, FAPWCA Director - The Centers for Wound Healing Springfield Hospital Springfield, PA Delaware County Memorial Hospital Drexel Hill, PA 1

2 Disclosures Speaker for KCI, an Acelity Company and BSN Medical 2

3 Important Information Prior to use of the SNAP Therapy System, it is important for the provider to consult the treating physician and read and understand all Instructions for Use, including Safety Information and Dressing Application Instructions. KCI recommends that clinicians participate in device in-service and training prior to use The following presentation includes case studies based on the speaker s individual clinical experience and research As with any case study, the results and outcomes should not be interpreted as a guarantee or warranty of similar results Individual results may vary depending on the patient s circumstances and condition Any opinions, findings, and conclusions or recommendations expressed in this presentation are those of the presenter, not necessarily those of KCI Unless otherwise indicated, all trademarks designated herein are proprietary to KCI Licensing, Inc., its affiliates and licensors. Rx only 3

4 Why is healing my wound so important? 4

5 The Cost of Diabetes 5

6 The Cost of Chronic Wounds Retrospective analysis: 2014 Medicare 5% Data Set Looked at prevalence and treatment cost for one or more: arterial ulcers, chronic ulcers, diabetic foot ulcers, diabetic infections, pressure ulcers, skin disorders, skin infections, surgical wounds, surgical infections, traumatic wounds, venous ulcers, or venous infections Result: Nearly 15% of Medicare beneficiaries (8.2 million) had at least one type of wound or infection Most prevalent: surgical and diabetic infections Most costly: surgical and diabetic wounds Total Medicare spending estimates for all wound types: $28.1 to $96.8 billion Site of service with highest cost: outpatient areas An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds Nussbaum S.R., Carter M.J., Fife C.E., DaVanzo J., Haught R., Nusgart M., Cartwright D. (2018) Value in Health, 21 (1), pp

7 How Do We Stop Wounds From Becoming Amputations? Good Wound Care History Advanced Wound Care Hyperbaric oxygen therapy Assessment Growth factors Debridement Manage moisture Off-load Topical care Nutrition Amniotic allografts Bioengineered tissue Negative Pressure Wound Therapy Biologic dressings Active topicals Plastic surgery Curative surgery 7

8 Wound Bed Preparation Developed by plastic surgeons A systematic approach to wound management Removes local barriers to wound healing Goal is a clean, healthy, well perfused wound bed Enables interventions to be more effective 8

9 TIME Principle of Wound Bed Preparation Tissue non viable or deficient Infection or inflammation Moisture imbalance Edge of wound non advancing or undermined Defective matrix and cell debris High bacterial counts or prolonged inflammation Desiccation or excess fluid Non-migrating keratinocytes Non-responsive wound cells Debridement NPWT Antimicrobials Debridement NPWT Dressings Compression NPWT Biological agents Skin grafts Debridement NPWT Restore wound base and ECM proteins Lower bacteria, protease levels; remove biofilm, reduce inflammation Restore cell migration; maceration avoided Stimulate keratinocyte migration Closure Schultz GS, Sibbald RG, Falanga V, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen 2003; 11(1 Suppl): S

10 What Drives Your Decision to Use NPWT? 10

11 Wound Depth? Exudate Level? Location? Wound Type? Insurance? What About the Patient?? 11

12 NPWT = Real-Life Challenges Patients still need to work Mobility can be a concern Weight of powered devices Fall risk Privacy Sleep disturbance 12

13 SNAP Therapy System Cases 13

14 Radiation Wound of the Axilla 65 year old female diabetic, s/p right breast cancer treated with lumpectomy, radiation, and chemotherapy in years later, noted serous drainage from pinhole wound in her right axilla Biopsy was (-) but surgical wound failed to heal

15 SNAP Therapy System Start 15

16 Two Weeks of SNAP System 16

17 Four Weeks of SNAP System KCI Licensing, KCI Licensing, Inc.,. Inc.,. All rights All rights reserved. reserved. GMAAP# O GMAAP# O 17

18 Wound Bed Preparation 18

19 Cryopreserved Skin 19

20 SNAP System Bolster 20

21 21

22 Fall Risk? KCI KCI Licensing, Inc.,. Inc.,. All All rights rights reserved. GMAAP# O 22

23 23

24 Healed Five Months 24

25 Venomous Insect Bite 58 year old male with suspected insect bite to left forearm Developed significant pain, swelling, and inflammation over 14 days

26 Post Incision & Drainage (I&D) 26

27 SNAP Therapy System Start 27

28 Three SNAP System Dressings 28

29 29

30 SNAP System Discontinued Three Weeks 30

31 Healed Five Weeks 31

32 Venous Leg Ulcer 73 year old male with long-standing VLU Failing multi-layer and pneumatic compression Non-complaint with activity and home care Poor exudate management dressing selection following biologic graft

33 Initial Presentation 33

34 ECM Collagen 34

35 35

36 SNAP Therapy System 36

37 Multilayer Compression 37

38 38

39 Three Weeks 39

40 SNAP System Discontinued 40

41 Post-Surgical Hand Wound 67 year old female s/p right thumb tenosuspension Developed post-operative wound infection and dehiscence Failed two separate revisions Deep residual wound exposing anastomosis

42 Initial Presentation KCI KCI Licensing, Licensing, Inc.,. Inc.,. All All rights rights reserved. reserved. GMAAP# O GMAAP# O 42

43 SNAP SecurRing Hydrocolloid + Window KCI KCI Licensing, Inc.,. Inc.,. All All rights rights reserved. GMAAP# O 43

44 Thumb Spica + Elastic 44

45 Three SNAP System Dressings (Two Weeks) 45

46 Traumatic Leg Wound Healthy 83-year-old female slipped off ladder, resulting in hematoma, cavity wound, and necrotic flap of the right anterior leg Measured 7 x 5 x 3 with 10-cm tunnel and extension to fascia/muscle

47 Initial Presentation 47

48 SNAP Therapy System Start 48

49 SNAP Therapy System Start 49

50 3 Days Later KCI KCI Licensing, Licensing, Inc.,. Inc.,. All All rights rights reserved. reserved. GMAAP# O GMAAP# O 50

51 Small Intestinal Submucosa (SIS) Matrix Graft 51

52 10 Days of SNAP Therapy 6 x 2.5 x x 2.2 x

53 4 Weeks s/p CELLUTOME Epidermal Harvesting System Days to Healing: 62 53

54 Chronic Leg Wound 47 year old female developed small left leg blister from poor-fitting boots Referred after 1 month of local care History of Type II diabetes, insulin use, ESRD, dialysis Arterial studies normal On transplant list

55 Initial Presentation 55

56 SNAP Therapy System Start 56

57 SNAP System Applied 58

58 5 SNAP System Dressings/18 Days 59

59 8 Days s/p CELLUTOME Epidermal Harvesting System 60

60 15 Days s/p CELLUTOME System 61

61 49 Days from SNAP System Start 62

62 Chronic Surgical Wound 69 year old female with left upper arm AV fistula site wound > 2 years History of ESRD s/p kidney transplant 2016, IDDM, CAD s/p CABG, right BKA Operative debridement of graft site abscess with poor healing Concurrent left leg ulcer 2018 KCI Licensing, Inc.,. All rights reserved. GMAAP#10091.O

63 Initial Presentation 64

64 SNAP System Application 65

65 4 Days of SNAP System 66

66 Hydrocolloid QOD x 7 Days CELLUTOME System Applied 68

67 One Month s/p CELLUTOME System Days to Healing: 49 69

68 DFU With Total Contact Cast (TCC) 55 year old obese male with Charcot arthropathy and right plantar midfoot ulcer History of IDDM, CVA, peripheral neuropathy, rocker bottom foot Strong pedal pulses Referred by DPM from office for TCC

69 Initial Presentation 71

70 Day 14: Refused TCC 72

71 Day 42: TCC #1 Applied 73

72 S/P TCC #6 : Stalled x 2 Weeks 74

73 Arterial Study Ankle Brachial Index (ABI)= 1.1 Toe Brachial Index (TBI)=

74 Radiograph 76

75 Biofilm/Bioburden? Aggressive Sharp Debridement 77

76 SNAP Therapy System, TCC 78

77 79

78 Day 8: Healed 4 Casts, 3 SNAP System Dressings 80

79 Indicated Wound Types Identical to V.A.C. Therapy The SNAP Therapy System is indicated for removal of small amounts of exudate from: Flap Wounds Chronic and Acute Wounds Subacute and Dehisced Wounds Traumatic Wounds Pressure Ulcers Partial Thickness Burns Grafts Although the wound types are identical, the wound characteristics (especially size & drainage) are different Surgically Closed Incisions Diabetic Foot Ulcers Venous Ulcers 81

80 SNAP Therapy System Contraindications Do not place the SNAP Therapy System over: Inadequately drained wounds Necrotic tissue such as eschar or adherent slough Exposed blood vessels, anastomotic sites, organs, tendons, or nerves Wounds containing malignancy Fistulas Untreated osteomyelitis Actively bleeding wounds 82

81 Armstrong (2012) Comparative Effectiveness of Mechanically and Electrically Powered Negative Pressure Wound Therapy Devices: A Multicenter Randomized Controlled Trial 83

82 Clinical Data Armstrong 1 In a multicenter RCT, 132 patients with lower extremity diabetic and venous wounds were enrolled in the study. 118 patients were treated either with SNAP Therapy (n=59) or V.A.C. Therapy (n=56), with 115 patients completing the study. Patients were treated for up to 16 weeks or complete wound closure. Primary end point analysis of wound size reduction found that SNAP Therapy treated subjects demonstrated non-inferiority to V.A.C. Therapy subjects at 4, 8, 12 and 16 weeks (p=0.0030, , and , respectively). The study indicated that the effect of the SNAP Therapy System was not significantly different than that of the V.A.C. Therapy System in promoting complete wound closure in the population studied (p=0.9620). SNAP Therapy patients reported less interruption of activities on daily living compared to V.A.C. Therapy patients. However, pain associated with treatment was not significantly different between treatment groups. Other benefits noted by the authors were shorter time to dressing application and ease of use. However, despite randomization, the initial wound size was significantly greater in the V.A.C. Therapy patients than in the SNAP Therapy patients (mean of 9.95 cm2 vs 5.37 cm2; p=0.0093) 84

83 How EP-NPWT Is Different from Mechanically Powered NPWT >13cm x 13cm >180mL/week Amount of drainage and wound size (Length x Width x Depth ) require ACTIV.A.C. Therapy Consider SNAP System as wound volume decreases and drainage subsides WOUND SIZE WOUND DRAINAGE ADDITIONAL CONSIDERATIONS 13cm x 13cm 180mL/week Consider for active, ambulatory, or elderly patients and those with limited access to electricity NPWT INITIATION COVERAGE CRITERIA* Previously Treated With Modern Wound Care; >Day 30 New Wound, First-Line Treatment; Day1 These wound criteria/clinical considerations are provided to help determine when to use SNAP Therapy versus ACTIV.A.C Therapy. They are not intended to replace the judgment and expertise of the treating physician. * May vary by payor. 85

84 SNAP Therapy System Value Proposition High Quality of Life (QOL) Scores Patient QOL exit survey findings: SNAP Therapy System vs V.A.C. Therapy System Less noticed in social situations Less noise Less interference with daily activities Less interference with sleep 86

85 7 SNAP Therapy System Warnings 1. It is a condition of use that the device will be operated under the supervision of a qualified and authorized clinical caregiver and that the user has the necessary training and knowledge of the specific medical application for which the SNAP Therapy System is being used. Failure to follow these conditions and/or to carefully read and follow all of the therapy unit usage and dressing application instructions and the safety information prior to each use may lead to improper device performance and the potential for serious or fatal injury. 2. The SNAP Therapy System has not been studied on pediatric patients. 3. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization will compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury or illness. 4. Do not use the Dressing on patients who are allergic to adhesives. 5. Do not compress contained wound exudate of gelled BIOLOCK material when resetting the SNAP Therapy Cartridge to prevent expulsion of exudate or BIOLOCK material. 6. Never leave the SNAP Therapy Dressing in place without active negative pressure therapy unless under clinical supervision. If the RED indicator becomes visible, negative pressure is no longer active. 7. Complete hemostasis should be achieved prior to use of the system as bleeding may interfere with the normal function of the SNAP Therapy System. 8. Extra care and monitoring is required for patients who are on anticoagulants or platelet-aggregation inhibitors because bleeding may interfere with the normal function of the SNAP Therapy System. 9. Care should be exercised if using the SNAP Therapy System on spinal cord injury patients; stimulus from placement, initiation or cessation of negative pressure may cause autonomic hyperreflexia. If a patient utilizing the SNAP Therapy System experiences autonomic dysreflexia, discontinue use of the system and seek medical assistance. 87

86 8 SNAP Therapy System Warnings (continued) 10. The Dressing should be removed prior to defibrillation if near the area of pad/paddle placement. 11. Fluid and electrolyte loss may result from highly exudative wounds. Close monitoring of electrolytes may be indicated in such cases. 12. Patients with severe malnutrition may be at higher risk for fluid loss from their wounds and may require more frequent monitoring. 13. To prevent ischemia, the Dressing should not be circumferentially placed around appendages, and the SNAP Therapy Strap should be worn as loosely as possible. 14. Discard if packaging is open or damaged. 15. Do not place the dressing materials into blind tunnels. 16. The primary foam interface should not be in direct contact with delicate structures such as tendons, ligaments and nerves. Use of a wide-mesh non-adherent, bio-engineered tissues or natural tissue structures should be utilized to cover and protect delicate structures. 17. During initial placement of the foam interface, count the total number of pieces placed in the wound and document this number per facility protocol. 18. During removal of the Dressing, ensure that all pieces, as documented during initial placement, and any fragments are removed from the wound. Unintentional dressing material retention for longer time periods than recommended may result in infection or other adverse events. 19. It is recommended that the Dressing be changed at a minimum of two times per week and the Cartridge be changed at a minimum of one time per week, with frequency adjusted by the clinician as appropriate. 88

87 9 SNAP Therapy System Warnings (continued) 20. Infected wounds should be monitored closely and may require more frequent dressing changes. Clinicians and patients/caregivers should frequently monitor the wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge, or strong odor. Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury. Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension, or erythroderma (a sunburn-like rash). If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact a physician immediately to determine if therapy should be discontinued. 21. Clinicians, caregivers and patients should frequently monitor the patient s wound, surrounding tissue and secreted exudate for signs of infection or other secondary conditions such as maceration or tissue necrosis. Infection can be severe and result in septic or toxic shock and/or fatal injury. 22. The SNAP Therapy Cartridge is not safe for use with magnetic resonance imaging (MRI) equipment. Do not use it inside an MRI suite. 23. Sharp edges such as bone fragments must be removed from the wound treatment area prior to placing the SNAP Therapy Dressing due to risk of puncturing the Dressing which will impair the proper function of the SNAP Therapy System, or could puncture blood vessels or organs resulting in injury. 24. Do not place the SNAP Therapy System on the vagus nerve to avoid inducing bradycardia. 25. Do not place the SNAP Therapy System on friable vessels or infected blood vessels. Infected or weakened vessels are more prone to damage, causing bleeding which will interfere with the function of the system. 89

88 0 SNAP Therapy System Precautions 1. Patient size and weight should be carefully considered when prescribing the SNAP Therapy System. 2. Care must be taken to position the Cartridge and Dressing tubing appropriately to prevent the risk of tripping and falling. 3. To reduce the risk of transmission of blood-borne pathogens, apply standard precautions for infection control with all patients, per institutional protocol. In addition to gloves, use gown and goggles if exposure to body fluids is likely. 4. The SNAP Therapy System may not be appropriate for treatment of noncompliant or combative patients. 5. Patients may bathe while using the SNAP Therapy System. However, patients should avoid getting the SNAP Therapy System wet. 6. The SNAP Therapy Cartridge and Strap are provided non-sterile and should not be sterilized. 7. The SNAP Therapy Cartridge and Dressing should be stored at room temperature only and should not be exposed to excessive cold or heat. 90

89 1 SNAP Therapy System Precautions Hyperbaric Oxygen Therapy (HBO) Do not take the SNAP Therapy Cartridge, the SNAP Therapy Strap or Tube Fitting into a Hyperbaric Oxygen (HBO) chamber as they have not been studied for use in this environment and could be considered a fire hazard. After disconnecting the Dressing Tubing from the Tube Fitting, cover the open end of the Dressing Tubing with cotton gauze. Alternatively, replace the SNAP Therapy Dressing with another HBO compatible material during the hyperbaric treatment. Do not clamp the tubing during HBO treatment. 91

90 Summary This is NPWT evolution, not revolution! Meant to augment, not replace, powered systems Easier to use for short periods/special populations Wound bed preparation Skin grafts Small, deep wounds Elderly with mobility issues Power source impaired (workers) Home care patients We will all find our way with it in practice Important to be coached at first Do not use for your worst train wreck Avoid one and done 92

91 Thank you. 93

92 Patient-Centric Wound Care: Case-Based Journeys with Leading-Edge Modalities Christopher L. Barrett, DPM, CWS, FAPWCA Director - The Centers for Wound Healing Springfield Hospital Springfield, PA Delaware County Memorial Hospital Drexel Hill, PA 94