Wound Vac Lecture
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  • 1. Diabetes, Wound Care and Prevention “From soup to nuts” 1
  • 2. Diabetic Wound Management Concepts • Diabetes affects 23.5 million people • 6.8% of the population • 18 million have been diagnosed • 5.5 million are undiagnosed • Healthcare costs of treating diabetes: 112 billion • There are currently 93,000 LEA per year • 3.7 million Blacks (13.4%) and 2.9 million (8.2%) Latinos 20+ have diabetes, with 26% of Latinos 45-74+ years of age with the disease • 51% of LEA occur in diabetics, but make up 6.8% of the population 2
  • 3. Diabetic Wound Management Concepts • 50-70% of diabetics present with peripheral neuropathy • 80% of amputees have peripheral vascular disease • 20% of diabetics have an amputation, with 30% requiring amputation of remaining limb in 3 years, 51% in 5 years • Risk of amputation in the diabetic is 40% higher than the common population • 5-7 year morality rate after below-knee amputation is >50% • 30-49 thousand deaths each year due to complications • Cost of ulcer treatment is 13.4 billion a year • Minorities are 2X-3X more likely to have an amp. 3
  • 4. Diabetic Wound Management Concepts • 25% of non-healing ulcers go on to an amputation • 84% of amputations started with a wound • By the time the amputation is done, hospitalization and wound care, with lost productivity will cost upwards of $120,000.00 • 19% of those with a minor amputation will go on to a major amputation in 6 months • Lower extremity (and especially foot) lesions are the most costly complication • 85% of amputations are preventable • Diabetes mellitus patients have a 40% higher risk of death after amp, compared to non-diabetics, with ½ dieing within 3 years 4
  • 5. Diabetic Wound Management Concepts • Primary: Type I Type II -non-obese -obese -maturity onset of the young • Secondary: Pancreatic (β-cell mass loss) Hormonal (pheochromocytoma, acromegaly, Cushing’s, steroids, Diabetes Insipidus—lack of vasopressin) Drug or chemical induced Insulin receptor abnormalities Genetic syndromes (lipodystrophy, myotonic dystrophy, ataxia/telangiectasia) 5
  • 6. Diabetic Wound Management Concepts • Type I – Genetic susceptible (HLAD region) – Environmental event (viral) – Insulinitis (action of T-lymphocytes) – Autoimmunity Due to β-cell attack (islet cell Ab) – Diabetes onset with loss of >90% of β-cells – Ketoacidosis requires decreased insulin and increased glucagon, leading to osmotic duresis and dehydration 6
  • 7. Diabetic Wound Management Concepts • Type II – Abnormal insulin secretion – Resistance to insulin @ target tissues Both β and α cell mass is intact, but α mass is increased – – Insulin levels are normal to high – No ketoacidosis, but a lactic acid induced hyperosmolar, non- ketoacidosis induced coma--HHNK (hyperglycemic, hyperosmolar, non-ketoacidosis) 7
  • 8. Diabetic Wound Management Concepts 8
  • 9. Diabetic Wound Management Concepts • Changes that lead to wounds and amputation – Autonomic neuropathy – Motor neuropathy – Sensory neuropathy • Leads to problems of – Autonomic neuropathic changes decrease pliability of skin – Motor neuropathic changes increase weightbearing forces at the foot – Sensory neuropathy is the leading cause of wounds leading to amputation 9
  • 10. Diabetic Wound Management Concepts • Changes in the tissue caused by increases in NADH (the reduced form of nicotinamide adenine dinucleotide, or NAD) generated by hyperglycemia and by hypoxia which mediates the complications of diabetes • Because NADH fuels several metabolic pathways implicated in the pathogenesis of diabetic complications and because hyperglycemia and hypoxia increase NADH by different mechanisms, researchers believe the combination of these two risk factors has the potential to accelerate the onset and progression of tissue damage • Hyperglycemia increases the rate of reduction of NAD to NADH, coupled to oxidation of sorbital whereas hypoxia increases NADH by limiting reoxidation of NADH to NAD Nyengaard J, Itlo Y, Kilo C, et at. Interaction between hyperglycemia and hypoxia: Implications for diabetic retinopathy. Diabetes 2004;53:2931-2938 10
  • 11. Diabetic Wound Management Concepts • Neuropathy – Loss of protective sensation – Loss of sebaceous gland function with dry skin – Loss of intrinsic musculature leading to hammertoes and weakness • Is present in 50-70% of diabetics • Increased sorbitol levels, decreased myoinositol, protein glycation, decreased axonal transport • Test by Semmes-Weinstein monofilament, aesthesiometry, Biothesiometry, Marstock stimulation (temperature ) 11
  • 12. Diabetic Wound Management Concepts • Immunopathy – Glycation (non-enzymatic) and glycosylation (enzymatic) of lymphocytes and macrophages – Erythrocyte fragility – Platelet adhesion • Desmopathy - Glycation of tendon and ligaments - Decreased ability to absorb shock - Decreased resiliency - Increased cross-linking of collagen with increased stiffness 12
  • 13. Diabetic Wound Management Concepts • Vasculopathy – Basement membrane thickening and calcification with ‘steal phenomena’ and capillary leaking of albumin with increased edema – Increased A/V shunting [possibly leading to Charcot neurotrophic osteoarthropathy] • Brodsky Classification • Eichenholtz Classification • Schon Classification – Decreased diapodesis – Concomitant risk factors: nicotine and hypercholesterolemia, homocystine levels 13
  • 14. Diabetic Wound Management Concepts • Combined causes leading to amputation – Loss of sensation causing increased chances of breakdown – Loss of muscle integrity causing changes in gait – Loss of intrinsic structural integrity causing hammertoes and metatarsalgia – Decreased ability of formed elements of blood to fight infection – Increase in platelet adhesion and thrombotic events with luminal changes – Combination of ischemia and neuropathy – Proteinuria and cardiovascular mortality – Albuminuria and vascular damage 14
  • 15. Diabetic Wound Management Concepts • Amputation patterns – Digit • 64% occurrence – Metatarsal head • 10% occurrence – Midfoot • 10% occurrence (associated with Charcot neurotrophic osteoarthropathy and not associated) – Calcaneal • 16% occurrence 15
  • 16. Diabetic Wound Management Concepts • Other manifestations of diabetes – Endothelial proliferation, intimal thickening, basement membrane thickening, increased platelet aggregation, decreased fibrinolytic activity – Necrobiosis lipoidica diabeticorum lesions – Diabetic bullosis – Disseminated granuloma annulare – Diabetic dermopathy – Carotinemia – Eruptive xanthomas – Rosenbloom’s syndrome – Acanthosis nigricans – Scleroderma diabeticorum – Porphyria cutanea tarda 16
  • 17. Diabetic Wound Management Concepts How do we approach this? – Biomechanical consideration to surgery • Retention of viable extremity • Reduction of further deformity leading to breakdown and infection • Possible need for a Tendo-Achilles lengthening – Ancillary • Antibiotics for 4-6 weeks with the avoidance of aminoglycosides • Use of topical growth factors, grafting materials, VAC (vacuum assisted closure) and HyperBaric Oxygen therapy • Proper shoes with fitted, molded innersoles • Regular follow-up with primary and lower-extremity specialist • Monitor albumin (3.5g/dl) and Tlympho (1500) for nutritional status and healing – Other considerations • congestive heart failure and edema decrease chance for healing 17
  • 18. How Do We Treat This? 18
  • 19. Assessing the Habitus of the Patient • General health of the patient will effect the ability to be compliant with weightbearing – Cardiac function – Osteoporosis – Osteoarthritis pain and disability • Look for pre-disposing conditions – Venous dermatitis which leads to venous status ulcers • Remember co-morbidities – Periodontal disease may increase mortality in patients with diabetes – Greater risk of coronary heart disease – Slowed cognitive-motor skills Endocrine Today, Feb, 2005 19
  • 20. Nutrition Status of Patient • Nutritional status of patient important – Remember the importance of zinc, arginine, folic acid, albumin levels – Some evidence that a mixture of bromelain, Vit C, rutin and grape seed extract will allow 17% faster healing 20
  • 21. Nutrition Status of Patient 21
  • 22. Testing Modalities • Vascular testing includes pulses (2/4 is normal) • Examination of digital hair distribution • Skin adnexa and skin quality looking for trophic changes • Capillary/venous plexus refill 22
  • 23. Testing Modalities • Vibratory response tests damage to Aβ fibers • Biothesiometry is better and repeatable (look for VPT (vibratory pressure threshold) of >25 to = 7X greater chance of wound formation 23
  • 24. Testing Modalities • Pressure testing to assess sharp sensation and damage to Aβ fibers • Standard is generally the Semmes/Weinstein 10g filament 24
  • 25. Testing Modalities • Proprioception testing to assess damage to Aα fibers 25
  • 26. Testing Modalities • Temperature* • ABI (ankle/brachial index) – Look for >45mm Hg, with a 1:1 ratio normal • TcPO2 (transcutaneous partial pressure of oxygen) – Look for >35mm • Doppler studies • Digital plethsmography *Lavery L, Higgins K, Lanctot D, et al. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004;27:2642-2647. 26
  • 27. Probing and Debriding the Wound • Finding the extent and depth of the wound dictates the debridement • Proper debridement of necrotic tissue is essential in any wound care attempt – Reduces bacterial count – Reduces MMPs (matrix metalloproteinases) 27
  • 28. Debriding the Wound 28
  • 29. Debriding the Wound • Keep in mind functional level during debridement • A Transmetatarsal amputation is more functional than a Lis-Franc and far more functional than a Chopart’s or below-knee amputation. 29
  • 30. Debriding the Wound Remove any slough and keep going until granular/viable tissue is encountered 30
  • 31. Debriding the Wound Although making the wound larger seems counter to the ideal of healing the wound, leaving non-viable tissue will sequester bacteria and inhibit healing efforts If it’s dead, it’s gotta go! 31
  • 32. Debriding the Wound 32
  • 33. Debriding the Wound 33
  • 34. Debriding the Wound 34
  • 35. Debriding the Wound Wet gangrene needs to go to the O.R. immediately to defervesce the area 35
  • 36. Debriding the Wound • Irrigation is important in debridement – Pulsed lavage is best – Added antibiotics have no proven benefit – Pressure should be in the 8-15mm Hg range • Bulb syringe is about 2mm Hg • 35cc syringe with 19ga. Needle = 8mm Hg 36
  • 37. Debriding the Wound • Don’t forget pathology • If it looks funky, send it • Even if it doesn’t look Squamous Cell Carcinoma funky, send it anyway 37
  • 38. Debriding the Wound • Accuzyme • Santyl (collagenase attacks necrotic tissue and perpendicular fibers of un-denatured collagen that bind necrotic tissue to the base of the ulcer) • Panafil (debriding and healing with papain/urea/copper/chlorophyllin complex) 38
  • 39. Culture of the Wound • Prep of the site and deep culture can help guide and narrow the focus of antibiotics 39
  • 40. Grading Ulcers • Wagner scale • UTHSCSA scale • Graduate Hospital • Others 40
  • 41. Phases of Wound Healing • Phase I – Hemostasis (coagulation cascade) • 0-2 hours • Platelet activation, adhesion, and aggregation; release of growth factors from platelets • Phase II – Inflammatory • 0-3 days • Neutrophils mount defense against bacteria using integrins; release cytokines to recruit fibroblasts and epithelial cells. Macrophages secrete growth factors and cytokines; signal transition from inflammatory to proliferative phase 41
  • 42. Phases of Wound Healing • Phase III – Reparative (proliferative) • 3-21 days • Cell-cell and cell-matrix communication for synthesis and deposition of granulation tissue, ingrowth of new blood vessels; wound contraction and epithelialization • Phase IV – Remodeling (maturation) • 2-weeks to over a year • Scar tissue transforms into stronger, more organized collagen bundles to improve tensile strength by cell-cell and cell-matrix interaction 42
  • 43. Wound Closure • Debride regularly • Keep wound surface moist • Normal healing is 10-15% decrease/week • Adjuncts are needed if rate is <15% – NPWT (negative pressure wound therapy) – Cultured skin and NPWT – Growth factors and ORC/Collagen – Hyperbaric oxygen therapy with growth factors 43
  • 44. Growth Factor Basics • PDWHF (platelet-derived wound healing factor) – Added to micro-crystalline collagen to form Avitene® • PDAF (platelet-derived angiogenesis factor) • PDEGF (platelet-derived epidermal growth factor) • TGFΒ (transforming growth factor-β) • PF-4 (platelet factor-4) • CTAPIII/βTG (connective tissue activating protein III/β-thromboglobulin) 44
  • 45. Growth Factor Basics • EGF (epidermal growth factor) Stimulates proliferation of mesodermal and ectodermal cells, fibroblasts and keratinocytes, respectively • FGF-β (fibroblast growth factor) Exerts a proliferative effect on epithelial cells, in vitro and in vivo • VEGF (vascular endothelial growth factor) The most prevalent, efficacious and long-term signal known to stimulate angiogenesis in wounds. VEGF expression is sensitive to copper and may be harnessed to accelerate wound contraction • IGF-1 (insulin-like growth factor) • KGF (keratinocyte growth factor) (Repifermin, Human Genome Sciences) • GM-CSF (granulocyte macrophage colony stimulating factor) A hematopoietic factor which stimulates proliferation and differentiation of hematopoietic progenitor cells and is typically used after chemotherapy to promote neutrophil recovery (Luekine, Immunex) •PDGF-BB (platelet-derived growth factor) –Of all growth factors tried on wounds, only this one has been successful in consistently healing wounds! 45
  • 46. Growth Factor Basics • PDGF is a mitogenic, chemoattractant for fibroblasts and smooth muscle cells, similar to the growth factor from macrophages. Triggers production of fibronectin, collagenase and hyaluronic acid in the gel matrix formation • PDAF is a non-mitogenic chemoattractant for capillary endothelial cells • PDEGF causes migration and mitosis of epidermal cells • TGFΒ is a chemoattractant for monocytes, inhibits endothelial cell mitosis and stimulates collagen and GAG (glycosaminoglycan) synthesis • PF-4 is a chemoattractant for neutrophils All are released from the α granules of platelets by thrombin 46
  • 47. Agents for Growth Factor Promotion • Panafil – Debrides and promotes healing with papain/urea/copper/chlorophyllin complex • Biafine WDE – Has trolamine/sodium alginate bringing macrophages to the site – Deep Dermal Hydration – Selective Macrophage Recruitment – Emollient Action – Replenishment of Natural Skin Barrier Function 47
  • 48. Agents for Healing • Hyperbaric oxygen therapy • Safe Blood Graft (APC+)[autologous, blood-derived tissue graft] • Promogran (45% oxidized regenerated cellulose [ORC] + 55% collagen) – Binds excess proteases in the wound and protects growth factors from destruction • Dermagraft – Neonatal dermal fibroblasts with normal level of collagen type III to type I GAGs 48
  • 49. Agents for Healing • Integra™ – Has the some of the advantages of an autograft without a donor site. Once the silicone sheet begins to separate with vascularization of the collagen matrix, it is removed and engineered tissue placed over this bed or STSG used • SIS – Porcine small intestine sub-mucosa extracellular matrix – OASIS The submucosa--found between the mucosal and muscular layers-- provides strength forms a three-dimensional matrix. Extracted to leave the complex matrix intact, the extracellular matrix material combines remarkable strength and flexible handling • Apligraf – Bilayer, bioenginered with 4 components (extracellular matrix, fibroblasts, keratinocytes, stratum corneum) on collagen 49
  • 50. Agents for Healing 50
  • 51. Agents for Healing • Hyalofill – Non-woven, soft, conformable, and absorbent biopolymeric fleece or ribbon entirely composed of HYAFF*, an ester of hyaluronic acid – breaks down upon contact with wound exudate, forming a soft, cohesive gel which provides a moist wound environment which is supportive of the healing process • Transcyte – Human Fibroblast Derived Temporary Skin Substitute - Temporary wound covering for surgically excised full thickness and partial thickness burns. • Epicel – For deep dermal or full-thickness wounds – Epicel is indicated for patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30% and in congenital nevus patients 51
  • 52. Agents for Healing • Silver (nonocrystalline silver) – Kills bacteria in less than 30 minutes with broad coverage, including MRSA (methacillin resistant Staphacoccus aureas), VRE (Vancomycin resistant Enterococcus), multidrug resistant Pseudomonas auriginosa and yeast with a double layer variety providing protection for up to 7 days – Acticoat (for burns) – Acticoat 7 (for wounds) Ag+ charge binds to the – charge of proteins and nucleic acids – Decreases MMPs (matrix metalloproteinases) activity, blocks respiratory cycle of bacterial cell wall membrane – Decreases excessive neutrophil response – Increases surface levels of calcium Contraindicated for 3rd degree burns and when using electrical stimulation – on the patient and will neutralize enzymatic debriding agents 52
  • 53. Agents for Healing • C-adexomer iodine – For wet, exudative wounds • Zinc Oxide – More than 300 enzymes are dependant on zinc for activity such as MMPs (matrix metalloproteinases). Also involved in nucleic acid and protein metabolism – Co-factor or component of more than 300 enzymes needed for wound repair. Can enhance re-epithelialization, decrease inflammation and decrease bacterial growth 53
  • 54. Agents for Healing • Honey (yes. HONEY!) – Effective against MRSA (methacillin resistant Staphacoccus aureas) and VRE (Vancomycin resistant Enterococcus) and is broadly anti-bacterial • OsteoSet Beads – Effective antibiotic delivery and healing potential even for soft tissue wounds 54
  • 55. Agents for Healing • Maggot therapy – Will only consume necrotic tissue and is effective for debridement of painful or complex wounds 55
  • 56. Agents for Healing • Penlac (Ciclopirox) – Broad spectrum antifungal and good antibacterial with anti- inflammatory properties. Has angiogenic activity and may have wound-healing potential. May stimulate hypoxia-induced factor (HIF-1) which regulates vascular endothelial growth factor (VEGF) • Exogen™ Bone Stimulator – Some early evidence that the ultrasound stimulation to the site of wound is angiogenic and stimulates healing. 56
  • 57. Agents for Healing • Anodyne Therapy – For increasing blood flow and improvement of neuropathic sensorium loss – Diabetic skin ulcers and other wounds healed much faster when exposed to the special LEDs and has shown that the LEDs also grow human muscle and skin cells up to five times faster than normal • Electrotherapy – Electrical stimulation as HVPC (high voltage pulsed current) to increase blood flow and stimulate growth factors. Pulse width varies with a range from 20-200 microseconds – Also, low intensity direct current (LIDC) in the range of 200 μA to 800 μA 57
  • 58. Agents for Healing • Electromagnetic Therapy – pulsed electromagnetic limb ulcer therapy (PELUT) – pulsed radio frequency signals (PRF), millimeter waves (MMW) and static magnetic fields (SMF) • Laser – The effects of low level or low intensity laser therapy (LLLT or LILT) on the overlapping phases of wound healing, i.e. inflammation, proliferation and remodeling, are such that acute injuries heal more rapidly 58
  • 59. Agents for Healing • Collagen Agents – Kollagen (Biocore) – Medifil (Biocore) – Skin Temp (Biocore) – Fibracol (J+J) – Collagen Wound Gel (J+J) – HyCure – Oasis (HealthPoint) – Xenaderm (Heathpoint) 59
  • 60. Agents for Healing Specifically PDGF-BB 60
  • 61. Agents for Healing (PDGF-BB) PDGF-BB Sends all 3 messages: Regranex® • Mitogenesis – Healing rate 48% • Chemotaxis – Mitogenic response initiating • Synthesis cell division To many cell types: • Fibroblasts • Macrophages, neutrophils • Endothelial cells • Smooth muscle cells 61
  • 62. Cells that produce Cells that PDGF Cellular response to PDGF PDGF acts on Stimulates proliferation and chemotaxis, stimulates production Fibroblasts, of matrix molecules (collagen, keratinocytes, Fibroblasts fibronectin, proteoglycans, etc.) smooth muscle cells, macrophages, Stimulates proliferation and platelets, chemotaxis, recruits smc to site of Smooth muscle endothelial cells new blood vessel formation cells Endothelial cells Stimulates proliferation and tube formation Neutrophils Stimulates chemotaxis Macrophages Stimulates chemotaxis, induces release of other GF’s 62
  • 63. Regranex® Sharp Debridement Improves Incidence of Complete Healing with PDGF-BB PDGF-BB gel 83% 100 Placebo Gel Percentage Healed 80 60 25% 40 20 0 0 20 40 60 80 100 Percentage of Office Visits Where Debridement Was Performed - Adapted from Steed DL. et. al. J Am Coll Surg 1996;183:61-64. 63
  • 64. Regranex® Key Biochemical Differences Between: -Healing Wounds • Large amounts and many types of Growth Factors • Low amounts of Proteases • Low amounts of Bacterial Toxins -NON-healing Wounds • Smaller amounts and fewer types of Growth Factors • High amounts of Proteases • Higher amounts of Bacterial Toxins 64
  • 65. Core Healing Principles Patient Factors Physical Aspects Macroscopic environment Microscopic environment 65
  • 66. Core Healing Principles Macroscopic environment Microscopic environment 66
  • 67. Core Healing Principles Macroscopic Environment 67
  • 68. Core Healing Principles Microscopic Environment • Excessive MMPs • Bioburden • Growth Factor Deficiencies • Proliferative Capacity • Abnormal Microcirculation • Excessive Inflammatory Mediators 68
  • 69. Regranex® • Accomplishes the goal of MMPs (matrix metalloproteinases) • Accomplishes the goal of essential growth factors in the wound environment 69
  • 70. Regranex® 70
  • 71. MMPs (matrix metalloproteinases) • Wound healing progresses through a series of processes, which include the formation of granulation tissue, epithelialization and connective tissue remodeling • These events require continuous modification of the complex cellular support matrix. • This matrix is comprised of structural proteins (collagen and elastin) • This matrix is comprised of specialized anchoring proteins (fibronectin, laminin and fibrillin) • Also comprised of proteoglycans and GAGs (gylcosaminoglycans) such as hyaluronic acid, chondroitin sulfate, heparan sulfate, heparin, dermatan sulfate and keratan sulfate • Blood vessels that deliver oxygen and nutrients to the extracellular matrix (ECM) also undergo modification 71
  • 72. MMPs (matrix metalloproteinases) A family of protein-degrading enzymes • 20 structurally related members • Need Calcium and Zinc ions for proper shape Zn • Made by every cell in the wound Ca • Collectively, can degrade all components of the extracellular Zn matrix Ca Zn Zn • Normally controlled by TIMPs (Tissue Ca Ca Inhibitors of Metalloproteinases) at the tissue level Zn Ca Zn Ca 72
  • 73. MMPs (matrix metalloproteinases) Protein-degrading Enzymes are Normally Secreted by Cells for: • Phagocytosis and debridement activity • Cellular migration over or through ECM • Remodeling of ECM during Maturation Phase of healing 73
  • 74. MMPs (matrix metalloproteinases) 74
  • 75. MMPs (matrix metalloproteinases) Level of MMPs in Wound Fluid Chronic Wound Healing MMP Level Normal Wound Healing Time to Healing 75
  • 76. MMPs (matrix metalloproteinases) What Causes Elevation of MMP’s? (and/or depletion of TIMP’s) • Local Factors • Systemic Factors – “fixable” – Not always fixable… • Elevated bacterial levels • Necrotic tissues 76
  • 77. MMPs (matrix metalloproteinases) Diabetes Increases MMP’s Lobmann R, Ambrosch A, Schultz G, Waldmann K, Schiweck S, Lehnert H. Expression of matrix-metalloproteinases and their inhibitors in the wounds of diabetic and non-diabetic patients. Diabetologia 2002 Jun;45(7):1011-6 Concentration of MMP-1 was increased 65-fold, MMP-2(pro)= increased 3-fold, 6- fold for MMP-2(active), 2-fold for MMP-8 and 14-fold for MMP-9 in biopsies of diabetic foot ulcers compared with traumatic wounds. Furthermore, the expression of TIMP-2 was reduced 2-fold in diabetic wounds. 77
  • 78. MMPs (matrix metalloproteinases) Aging Increases MMP’s Ashcroft GS, Horan MA, Herrick SE, Tarnuzzer RW, Schultz GS, Ferguson MW. Age-related differences in the temporal and spatial regulation of matrix metalloproteinases (MMPs) in normal skin and acute cutaneous wounds of healthy humans. Cell Tissue Res 1997 Dec;290(3):581-91 78
  • 79. MMPs (matrix metalloproteinases) Smoking Increases MMP’s Knuutinen et al. Smoking affects collagen synthesis and extracellular matrix turnover in human skin. Br J Dermatol 2002 Apr;146(4):588-94. • The levels of MMP-8 were 100% higher and of TIMP-1 were 14% lower in the smokers than in the non-smokers 79
  • 80. Reduction of MMP’s ORC Collagen 45% 55% • Combination of collagen and Oxidized Regenerated Cellulose • A proprietary biomaterial with the combined properties of both materials 80
  • 81. Effect of ORC/Collagen on MMP Activity in Chronic Wound Fluid 100 MMP ACTIVITY 80 60 CONTROL 40 GAUZE 20 ORC/COLLAGEN 0 0 0.25 0.5 1 2 24 TIME (hour) 81
  • 82. Protection of PDGF-BB by ORC/Collagen in Chronic Wound Fluid BOUND 100 FREE % Recovery of Theoretical 80 60 40 20 0 PDGF PDGF PDGF PDGF Wound Fluid Wound Wound Fluid Gauze Fluid ORC/Collagen 82
  • 83. A New Tool in Wound Management: ORC/Collagen • A tool to modify the hostile chemistry of the non- healing wound environment to more closely resemble that of a healing wound • By decreasing destructive enzyme levels which may in turn allow endogenous/exogenous growth factor survival in the wound bed 83
  • 84. Promogran® This ORC/collagen matrix dressing provides an environment which attracts cells and supports tissue growth. This dressing is used for multiple types of wounds including diabetic foot ulcers, venous ulcers, and pressure ulcers. Promogran matrix is a primary dressing which transforms into a soft, comfortable gel, allowing contact with the entire wound bed. 84
  • 85. Use of the VAC For Wound Healing Background 85
  • 86. Early animal research by Argenta & Morykwas Studied the effect of Negative Pressure Wound Therapy on: • Clearance of bacteria from infected wounds • Blood flow in the wound • Rates of granulation tissue formation Source: Morykwas, Argenta, et al., 558 Courtesy of KCI, San Antonio, TX 06/04 86
  • 87. Bacterial Clearance – significant decrease in number of microorganisms 12 9 6 Log Organisms* 3 *Standard is 105. 0 Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 7 Clinical Infection NPWT Control Source: Morykwas, Argenta, et al., 558 Courtesy of KCI, San Antonio, TX 06/04 87
  • 88. Blood Flow Increased (125mmHg) Perfusion Units Blood Flow at 125 mmHg OFF OFF Time in Minutes Figure 1 Pressure ON Source: Morykwas, Argenta, et al., 557-58 Courtesy of KCI, San Antonio, TX 06/04 88
  • 89. Blood Flow Decreased (400mmHg) Perfusion Units Blood Flow at 400 mmHg OFF OFF Figure 2 Time in Minutes Pressure ON Source: Morykwas, Argenta, et al., 557-58 Courtesy of KCI, San Antonio, TX 06/04 89
  • 90. Percent of Granulation Tissue Increased tissue formation compared to 103.4 120 % Increase in granulation saline Wet to Moist 100 63.3 80 60 40 20 0 Continuous Intermittent Source: Morykwas, Argenta, et al., 556-57 Courtesy of KCI, San Antonio, TX 06/04 90
  • 91. Clinical Efficacy and Cost Effectiveness Shorter length of stay and healing costs 38% less* *Estimated cost of saline and gauze **Based on predicted median reimbursement ***Visit required every 2 days *Based on published study. Individual results may vary. Source: Philbeck, et al. Courtesy of KCI, San Antonio, TX 06/04 91
  • 92. A Prospective Randomized Trial* *Based on published study. Individual results may vary. Change in Depth Change in Width 70 80 % Reduction in Depth % Reduction in Width 70 60 60 50 50 Figure 1 40 Figure 2 40 30 30 20 20 10 10 0 0 0 Weeks 3 Weeks 6 Weeks 0 Weeks 3 Weeks 6 Weeks V.A.C. ® Therapy Time of Reduction Time of Reduction p=0.00001 p=0.02 WM Change in Length Change in Volume 100 50 % Reduction in Volume % Reduction in Length 80 40 30 60 Figure 3 Figure 4 20 40 10 20 0 0 0 Weeks 3 Weeks 6 Weeks 0 Weeks 6 Weeks Time of Reduction Time of Reduction p=0.038 P=0.038 Source: Joseph, E., et al., Wounds 2000 Courtesy of KCI, San Antonio, TX 06/04 92
  • 93. Carl T. Hayden VA Medical Center Analysis* *Based on published study. Individual results may vary. Initial Admission Days & Days to Healing Complications & Additional Surgery 160 158.2 1.24 1.4 140 1.2 113.4 120 1 100 78.6 Per Patien Days 0.68 0.8 80 60 0.6 0.4 0.35 40 27.8 0.4 16.7 15.5 20 0.2 0 0 Admit Days Days to Fill Days to Heal Complications Surgery (p<0.0001) (p=0.04) (p<0.0001) (p=0.01) Readmits & Readmit Days 10 8.44 8 Readmits, Days V.A.C.® Therapy 6 4 Wet-to-Dry 1.3 2 0.68 0.15 0 Source: Page, Jeffery DPM., et al. Readmits Readmit Days Courtesy of KCI, San Antonio, TX 06/04 (p=0.001) 93
  • 94. Economic Value – Studies Showed • V.A.C.® Therapy in the home is more effective than standard care based on both cost and wound outcomes. • V.A.C.® Therapy could result in potential per patient savings of approximately $1,542 across all care settings. * Based on published study. Individual results may vary. Source: Williams, et al. Courtesy of KCI, San Antonio, TX 06/04 94
  • 95. ® V.A.C. Therapy Indications for use: • V.A.C.® family of devices with woundsite feedback control are negative pressure devices used to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site. • The V.A.C.® Instill™ System is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. Source: V.A.C.® family of devices, 510(k) No.K032310 V.A.C.®Instill™, 510(k)No.K021501 Courtesy of KCI, San Antonio, TX 06/04 95
  • 96. Indicated Wound Types: • Acute • Chronic • Traumatic • Partial Thickness Burns • Dehisced wounds • Diabetic Ulcers • Pressure Ulcers • Flaps and Grafts Sources: V.A.C.® Therapy Clinical Guidelines, p.3; Courtesy of KCI, San Antonio, TX 06/04 96
  • 97. ® V.A.C. Therapy Precautions • Active bleeding • Difficult wound hemostasis Continued… • Anticoagulants • Dressing in close proximity to blood vessels or visceral organs requires protective barrier Vascular Organs Sources: V.A.C.® Therapy Clinical Guidelines, p.3; Courtesy of KCI, San Antonio, TX 06/04 97
  • 98. V.A.C. Therapy Precautions ® • Weakened, irradiated or sutured blood vessels or organs • Bone fragments or sharp edges • Enteric fistula* • Follow universal precautions Tendon Bone *Wounds with enteric fistula require special precautions to optimize V.A.C.® Therapy. For recommended guidelines, refer to V.A.C.® Clinical Therapy Guidelines, p.3. Courtesy of KCI, San Antonio, TX 06/04 98
  • 99. V.A.C.® Instill™ System Additional Precautions • The V.A.C.® Instill™ System is intended for use with saline solutions in a physiologic pH range* that can optionally include topical wound treatment solutions. • Various topical agents such as hydrogen peroxide are not intended for extended tissue contact. If in doubt about the appropriateness of using a solution for Instillation Therapy™, contact the solution’s manufacturer. • Do not introduce solutions in conflict with manufacturer’s instructions for use. *pH of 6.0 – 7.4 per Guyton, AC. “Textbook of Medical Physiology” 8th ed. 1991. For recommended guidelines, refer to V.A.C.® Instill™ Recommended Guidelines, p.4. Courtesy of KCI, San Antonio, TX 06/04 99
  • 100. V.A.C.® Instill™ System Additional Precautions • During the Hold (dwell) period of Instillation Therapy™, the V.A.C.® Dressing system is a closed system and is NOT vented to atmosphere. • Do not use where temperature of fluid could cause an adverse reaction, such as a change in patient’s core body temperature. • Application of Instillation Therapy™ will result in pauses of negative pressure to the wound. Additional consideration and Physician discretion is advised when using Instillation Therapy™ on wounds requiring Continuous V.A.C.® Therapy (as opposed to ‘Intermittent’), such as enteric fistulas and fresh flaps and grafts. Source: V.A.C.® Instill™Recommended Guidelines, p.4 Courtesy of KCI, San Antonio, TX 06/04 100
  • 101. V.A.C.® Therapy Contraindications • Untreated Osteomyelitis • Malignancy in the wound • Placement of V.A.C.® dressings over exposed blood vessels or organs • Non-enteric and unexplored fistula • Necrotic tissue with eschar present Source: V.A.C.® Therapy Clinical Guidelines, p.3 Courtesy of KCI, San Antonio, TX 06/04 101
  • 102. V.A.C.® Instill™ System Additional Contraindications • KCI dressing systems are also contraindicated for use with hydrogen peroxide and solutions that are alcohol based or contain alcohol. • It is not recommended to deliver fluids to the thoracic cavity. Source: V.A.C.® Instill™ Recommended Guidelines, p.4 Courtesy of KCI, San Antonio, TX 06/04 102
  • 103. ® V.A.C. Therapy Summary • Applies controlled, localized negative pressure to help uniformly draw wounds closed • Helps remove interstitial fluid allowing tissue decompression • Helps remove infectious materials • Provides a closed, moist wound healing environment • Assists granulation* • Helps promote flap and graft survival *Joseph, et al, WOUNDS 2000. 12 (3); 60-67 Source: Advanced Wound Dressings Brochure Courtesy of KCI, San Antonio, TX 06/04 103
  • 104. ® V.A.C. Instill™ System Summary • Provides automated topical solution delivery to and removal from the wound site • Helps assist with wound cleansing irrigation and removal of infectious materials • Helps remove interstitial fluid allowing decompression • Helps minimize manual irrigation and time-consuming caregiver intervention Source: V.A.C.® Instill™ Brochure Courtesy of KCI, San Antonio, TX 06/04 104
  • 105. ® V.A.C. Therapy System --Major Components • Therapy delivery unit • T.R.A.C.™ tubing • V.A.C.® canisters • Application specific dressings • Semi-occlusive drapes Courtesy of KCI, San Antonio, TX 06/04 105
  • 106. ® ™ Dressings – V.A.C. GranuFoam Polyurethane Small, medium, large Heel dressing and extra large foam Thin and round foam Abdominal dressing Source: Advanced Wound Dressings Brochure; V.A.C.® GranuFoam™ Heel Dressing Brochure Courtesy of KCI, San Antonio, TX 06/04 106
  • 107. ® ™ Dressings – V.A.C. VersaFoam Polyvinyl alcohol Small and Large Source: Advanced Wound Dressings Brochure Courtesy of KCI, San Antonio, TX 06/04 107
  • 108. Dressings – Choosing Foam* *All foam dressing kits are packaged sterile. The chart on this slide shows the recommended guidelines for when to use each type of foam during V.A.C.® Therapy. Physician guidance should always be followed as individual circumstances may vary. Source: V.A.C.® Clinical Therapy Guidelines, p.6 Courtesy of KCI, San Antonio, TX 06/04 108
  • 109. V.A.C.® and Bioengineered Skin Technique • Clean base • If using the black polyurethane foam dressing, cover the bioengineered skin with a single layer, non-adherent, open pore dressing first. Apply the black polyurethane foam dressing on top • If using the white, polyvinyl alcohol foam dressing, place the dressing directly over the graft • 75-125mm Hg continuous suction • 72-96 hours duration 109
  • 110. Dressing Application •Cut foam to fit size and shape of wound •Do not cut foam over wound •Rub edges of foam to remove loose pieces Courtesy of KCI, San Antonio, TX 06/04 110
  • 111. Dressing Application • Place foam into wound cavity • Count pieces of foam • Annotate total number in chart and on drape 111
  • 112. Dressing Application • Trim the drape • Cover foam • 3-5cm border intact skin 112
  • 113. Dressing Application • Cut 2cm hole in drape and apply T.R.A.C. Pad™ 113
  • 114. Dressing Application 114
  • 115. T.R.A.C. Technology TM ™ 115 Courtesy of KCI, San Antonio, TX 06/04 Slide 27, Rev 06/04
  • 116. ® V.A.C. Therapy Systems ® V.A.C. Classic System V.A.C. System ® ATS FP ® Freedom V.A.C. System ® V.A.C. System Instill™ Source: V.A.C.® Therapy Clinical Guidelines, p.8 Courtesy of KCI, San Antonio, TX 06/04 116
  • 117. V.A.C.® Therapy Care and Safety Tips Keep therapy on: Never leave sub-atmospheric pressure off for more than 2 hours per 24 hour period. Remove V.A.C.® dressing if sub-atmospheric pressure is terminated or is off for more than 2 hours in a 24 hour period. Dressing changes: Perform aggressive wound cleaning per physician order prior to dressing application. Routine dressing changes should occur every 48 hours. Dressing changes for infected wounds should be accomplished every 12-24 hours. Always replace with sterile V.A.C.® disposables from unopened packages. Follow established institution protocols regarding clean versus sterile technique. Source: V.A.C.® Therapy Clinical Guidelines, p.3-4 Courtesy of KCI, San Antonio, TX 06/04 117
  • 118. V.A.C.® Therapy Care and Safety Tips Monitoring the wound: Inspect the dressing frequently to ensure foam is collapsed and negative pressure is being delivered in a consistent manner. Monitor periwound tissue and exudate for signs of infection or other complications. Signs of possible infection may include fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound area, purulent discharge or a strong odor. Nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucous membrane, disorientation, high fever (>102° F, 38.8°C), refractory hypotension, orthostatic hypotension, or erythroderma (sunburn-like rash) may be added signs of more serious complications of infection. Extra care and attention should be given if there are signs of possible infection or related complications. Infection can be serious. With or without V.A.C.® Therapy, infection can lead to many adverse complications including pain, discomfort, fever, gangrene, toxic shock, septic shock and various other complications. Source: V.A.C.® Therapy Clinical Guidelines, p.3-4 Courtesy of KCI, San Antonio, TX 06/04 118
  • 119. V.A.C.® Therapy Care and Safety Tips If dressing adheres to wound: Instill sterile water or normal saline into the dressing and let it set for 15-30 minutes, then gently remove from the wound. Consider placing a single layer, wide meshed, non- adherent dressing (Adaptic or Mepitel) prior to foam placement. Discomfort: If patient complains of discomfort throughout therapy, consider changing to V.A.C.® VersaFoam™ (PVA) Dressing. If patient complains of discomfort during the dressing change, consider pre- medication, use of non-adherent prior to foam placement or instillation of a topical anesthetic agent such a 1% lidocaine prior to dressing removal. Source: V.A.C.® Therapy Clinical Guidelines, p.4 Courtesy of KCI, San Antonio, TX 06/04 119
  • 120. V.A.C.® Therapy Care and Safety Tips Unstable structures: Over unstable body structures such as unstable chest wall or non-intact fascia, use continuous (not intermittent) therapy to minimize movement and help stabilize the wound bed. Spinal cord injury: In the event a patient experiences autonomic hyperreflexia (sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervous system) discontinue V.A.C.® Therapy to help minimize sensory stimulation Source: V.A.C.® Therapy Clinical Guidelines, p 4 Courtesy of KCI, San Antonio, TX 06/04 120
  • 121. V.A.C.® Therapy Care and Safety Tips Body cavity wounds: Underlying structures must be covered by natural tissues or synthetic materials that form a complete barrier between the underlying structures and the V.A.C.® foam. V.A.C.® dressing use: All V.A.C.® dressings distributed by KCI are to be used exclusively with V.A.C.® Therapy units, and vice versa Source: V.A.C.® Therapy Clinical Guidelines, p 4 Courtesy of KCI, San Antonio, TX 06/04 121
  • 122. V.A.C.® Therapy Care and Safety Tips Canister changes: Monitor fluid level in canisters frequently during Instillation Therapy™ to accommodate canister changes resulting from wound treatment solution and exudate removal. V.A.C.® canister should be changed when full. At a minimum, the canister should be changed weekly and disposed of properly, as it may contain body fluids. Follow Universal Precautions. Source: V.A.C.® Therapy Clinical Guidelines, p 4 Courtesy of KCI, San Antonio, TX 06/04 122
  • 123. V.A.C.® Therapy Care and Safety Tips • WARNING: Do not pack the foam into any areas of the wound. Forcing foam dressings in a compressed manner into any wound is contrary to approved KCI guidelines, and KCI questions whether such practices may increase the risk of serious adverse health conditions. Be sure to comply with all other CONTRAINDICATIONS and PRECAUTIONS included with the V.A.C.® System. 123
  • 124. Optimizing Therapy And the wound must be: To help optimize the benefits of V.A.C.® Therapy, the patient must: • Debrided of eschar and hardened slough • Maintain active negative pressure • Free of osteomyelitis, or receiving therapy for 22 of 24 hours per day current antibiotic treatment • Receive clinical evaluation and therapy guidance on a regular basis • Free of malignancy • Address compromising nutritional • Adequately perfused to allow issues healing Source: V.A.C.® Therapy Clinical Guidelines, pp.4-5 Courtesy of KCI, San Antonio, TX 06/04 124 Slide 35, Rev 06/04
  • 125. Advantages of VAC® • Allows a moist wound environment • Manages exudate • Infection control via control of bacterial burden with negative pressure – Negative pressure of 125mm Hg – Causes 4X increase in blood flow – Decreases bacterial counts – Increases angiogenesis – Increases growth factors • Wound heating • Stimulation of cells via Thomas’ Law 125
  • 126. List of Reference Sources L. Remington, Publishers Message, The Remington Report, Volume 11, Issue 3, May/June, 2003 at 1. Robert H. Demling, MD, and Leslie DeSanti, RN, Protein-Energy Malnutrition and the Nonhealing Cutaneous Wound, CME, Medscape, July 9, 2003. Morykwas, Argenta, et al., Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Animal Studies and Basic Foundation, Annals of Plastic Surgery, Vol. 38, No.6, June 1997 Philbeck, et al., The Clinical Cost Effectiveness of Externally Applied Negative Pressure Wound Therapy in the Treatment of Wounds in Home Healthcare Medicare Patients, Ostomy/Wound Management, January 1999; 45 (11): 41-50. Joseph, E., et el., A Prospective Randomized Trial of Vacuum-Assisted Closure Versus Standard Therapy of Chronic Nonhealing Wounds, WOUNDS, Vol. 12, No. 3, May/June, 2000, pp. 60-67. Page, Jeffery DPM., et al., the Use of Negative Pressure Therapy in the Treatment of Wounds with Significant Soft Tissue Defects, Carl T. Hayden VA Medical Center, Phoenix, Arizona. Presented, August 2002. American Podiatric Medical Association, Annual Society Conference. 126
  • 127. List of Reference Sources Williams, et al., Economic Assessment of KCI USA’s V.A.C.® Therapy Device, White Paper, Feb., 2002, prepared by Milliman. Milliman is a firm of consultants and actuaries serving the full spectrum of business, governmental, and financial organizations. It is known broadly as a leader in assessing risk within the healthcare environment. Milliman is a founding member of Milliman Global, an international network of insurance and benefits consulting firms with more than 100 offices in over 30 countries. Sue Mendez-Eastman, RN, CWCN is from the Plastic Surgical Center of Nebraska Health System, Center for Wound Healing at Clarkson, Omaha, Nebraska. Dr. Kaplan, Philadelphia, PA Joseph A. Molnar, MD, Ph.D.; Mark D. Wigod, MD; Anoush Hadaegh, MD; Anthony J. DeFranzo, MD; Malcolm M. Marks, MD; Louis C. Argenta, MD. Department of Plastic and Reconstructive Surgery, Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina. Scottsdale Healthcare - Osborn, Scottsdale Arizona. Treating physician: Dennis E. Weiland, MD. & John M. Stein, MD. David G. Armstrong, DPM, Southern Arizona VA Health Care System. Gregory J. Bauer. MD., Assistant Professor of Surgery, Cornell University 127
  • 128. List of Reference Sources Advanced Wound Dressings Brochure V.A.C.® GranuFoam™ Heel Dressing Brochure V.A.C.® Therapy Clinical Guidelines V.A.C.® Instill™ Recommended Guidelines 128
  • 129. Case Studies • VAC® alone • With other modalities 129
  • 130. Case Studies • Use black foam polyurethane for pressure and diabetic wounds, deep wounds • Larger pores • Better for stimulation of granulation tissue and wound contraction • Use white polyvinylalcohol for superficial or painful wounds • Denser, with smaller pores • Less granulation tissue • Use for vascular wounds • Use over tendons • Use strips of Aquacel around the wound borders to control seepage and maceration 130
  • 131. VAC® alone 5 weeks later Venous stasis ulceration, lateral malleolus 131
  • 132. VAC® with Regranex® and Mepitel® 132
  • 133. VAC® with Regranex® and Promogran® 133
  • 134. VAC® with Acticoat® 134
  • 135. VAC® with APC+ with Promogran® 135
  • 136. VAC® with Apligraf® 2 applications later 136
  • 137. VAC® with Promogran® 137
  • 138. VAC® with Dermagraft® 138
  • 139. VAC® with Integra™ • Bilayer matrix that mimics dermal and epidermal function • The dermal component is a porous biodegradable matrix of collagen GAG (glycosaminoglycan) from shark cartilage • Dermal layer bound to a temporary epidermal substitute layer of semi-permeable polysiloxan to control moisture 139
  • 140. VAC® with Oasis® 140
  • 141. VAC® with skin graft 141
  • 142. VAC® with skin graft 142
  • 143. Other Healing Modalities Free, Transpositional and Rotation Flaps All amenable to VAC® therapy to increase viability 143
  • 144. Island Flap 144
  • 145. Rotational Flap 145
  • 146. Transpositional Flap 146
  • 147. Off-loading of Site • Use of total contact casting • Use of patellar tendon bearing brace 147
  • 148. Guidelines for Patients • Check feet daily • Wear shoes at all times • Shake out shoes before wearing • Wear proper fitting shoes • Don’t use hot water on your feet • Check glucose levels every day • Visit primary care doctor regularly • Visit foot care specialist regularly • Attend diabetic classes Good shoes Not good shoes 148
  • 149. Wound Assessment Algorithm 149
  • 150. Thank You 150