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
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
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
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
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
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
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
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
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
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
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
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
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
69. Regranex®
• Accomplishes the goal of MMPs
(matrix metalloproteinases)
• Accomplishes the goal of essential
growth factors in the wound
environment
69
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
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
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
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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
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
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
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
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
