Diabetic Wound Care

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
 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.
 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
 Type I
– Genetic susceptible (HLAD region)
– Environmental event (viral)
– Insulinitis (action of T-lymphocytes)
– Autoimmunity
– Due to -cell attack (islet cell Ab)
– Diabetes onset with loss of >90% of -cells

 Ketoacidosis requires decreased insulin and increased

glucagon, leading to osmotic duresis and dehydration
 Type II
– Abnormal insulin secretion
– Resistance to insulin @ target tissues
– Both  and  cell mass is intact, but  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)
What happen in Diabetic?
 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
 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
 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 T)
 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
 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
 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
 Amputation patterns
– Digit
 64% occurrence
– Metatarsal head
 10% occurrence
– Midfoot
 10% occurrence (associated with Charcot neurotrophic osteoarthropathy and not
associated)
– Calcaneal
 16% occurrence
How to Approach?
 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
Assest 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

Nutritional State
 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
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
 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
 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

20
 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

21
Probing 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)
 Remove any slough and keep going until
granular/viable tissue is encountered
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
 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
 Don’t forget pathology
 If it looks funky, send it
 Even if it doesn’t look funky, send it anyway
 Wet gangrene needs to go to the O.R.
immediately to defervesce the area
 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)
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
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)
• TGF (transforming growth factor-)
• PF-4 (platelet factor-4)
• CTAPIII/TG (connective tissue activating
protein III/-thromboglobulin)
• EGF (epidermal growth factor) Stimulates proliferation of mesodermal
and ectodermal cells, fibroblasts and keratinocytes, respectively
• FGF- (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!
• 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
• TGF 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  granules of platelets by thrombin

Agent 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
Agent 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
  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
 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
 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
 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
 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
 Maggot therapy
 – Will only consume necrotic tissue and is effective for
debridement of painful or complex wounds
 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.
 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 A
to 800
 A
 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
 Collagen Agents
– Kollagen (Biocore)
– Medifil (Biocore)
– Skin Temp (Biocore)
– Fibracol (J+J)
– Collagen Wound Gel (J+J)
– HyCure
– Oasis (HealthPoint)
– Xenaderm (Heathpoint
PDGF-BB Sends all 3 messages:
 Mitogenesis
 Chemotaxis
 Synthesis
 To many cell types:
 Fibroblasts
 Macrophages, neutrophils
 Endothelial cells
 Smooth muscle cells
 Regranex®
 Healing rate 48%
 Mitogenic response initiating cell division
Cells that produce Cells that PDGF Cellular response to PDGF
PDGF acts on
Stimulates proliferation and
Fibroblasts, chemotaxis, stimulates production
keratinocytes, of matrix molecules (collagen,
Fibroblasts
smooth muscle fibronectin, proteoglycans, etc.)
cells,
macrophages,
platelets, Stimulates proliferation and
endothelial cells Smooth muscle chemotaxis, recruits smc to site of
cells new blood vessel formation

Endothelial cells Stimulates proliferation and tube

formation
Neutrophils Stimulates chemotaxis
Macrophages Stimulates chemotaxis, induces
release of other GF’s

52
 Regranex®
Sharp Debridement Improves Incidence of Complete Healing with PDGF-BB

PDGF-BB gel 83%

100 Placebo Gel
Percentage Healed

80

60

40 25%

20

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.

53
  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

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
  A family of protein-degrading enzymes
 20 structurally related members
 Need Calcium and Zinc ions for proper
shape
 Made by every cell in the wound
 Collectively, can degrade all components of
the extracellular matrix
 Normally controlled by TIMPs (Tissue Inhibitors
of Metalloproteinases) at the tissue level
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
 MMPs (matrix
metalloproteinases)
Level of MMPs in Wound Fluid

Chronic Wound Healing

MMP Level

Normal Wound Healing

Time to Healing

59
 MMPs (matrix
metalloproteinases)
What Causes Elevation of MMP’s?
(and/or depletion of TIMP’s)

• Local Factors • Systemic Factors

– “fixable” – Not always

• Elevated bacterial levels fixable…
• Necrotic tissues

60
 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.

61
 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

62
 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

63
 Reduction of
MMP’s
Collagen ORC
55%
45%
• Combination of collagen and Oxidized Regenerated
Cellulose
• A proprietary biomaterial with the combined properties of
both materials

64
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)

65
 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 Wound Fluid Wound Fluid
Fluid Gauze ORC/Collagen

66
 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

67
 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.

68
Use of the VAC For Wound
Healing
Background

69
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

70
 Bacterial Clearance – significant
decrease in number of
microorganisms
12

6
Log Organisms*

3 *Standard is 105.

0
Day 0 Day 1 Day 2 Day 3 Day 4 Day Day 7
5

Clinical Infection NPWT Source: Morykwas, Argenta, et al., 558

Control Courtesy of KCI, San Antonio, TX 06/04

71
Blood Flow Increased
(125mmHg)
Perfusion Units

Blood Flow at 125 mmHg

Figure 1 Time in Minutes

Source: Morykwas, Argenta, et al., 557-58

Courtesy of KCI, San Antonio, TX 06/04

72
 Blood Flow Decreased
(400mmHg)
Perfusion Units

Blood Flow at 400 mmHg

Figure 2
Time in Minutes

Source: Morykwas, Argenta, et al., 557-58

Courtesy of KCI, San Antonio, TX 06/04

73
 Percent of Granulation Tissue
Increased
103.
tissue formation compared

120
% Increase in granulation

4
to saline Wet to Moist

100

80 63.
3
60

40

20

0
Continuo Intermittent
us
Source: Morykwas, Argenta, et al., 556-57

Courtesy of KCI, San Antonio, TX 06/04

74
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

75
A Prospective Randomized
Trial* Change in Depth *Based on published study. Individual results may vary.

Change in Width
80 70
% Reduction in Depth 70 60

% Reduction in Width
60 50
50
Figure 1 40
40
30
Figure 2 30
20 20
10 10
0 0
0 Weeks 3 Weeks 6 Weeks 0 Weeks 3 Weeks 6 Weeks
Time of Reduction ®
p=0.00001
V.A.C. Therapy Time of Reduction
p=0.02

WM
50
Change in Length 100
Change in Volume
40 80

% Reduction in Volume
% Reduction in Length

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

76
 Carl T. Hayden VA Medical Center
Analysis*
*Based on published study. Individual results may vary.

Initial Admission Days & Days to Healing Complications & Additional

160 158.2
Surgery
1.4 1.24
140
120 113.4 1.2
100 1
78.6

Per Patien
Days

80 0.8 0.68
60 0.6
0.35 0.4
40 27.8 0.4
16.7 15.5
20
0.2
0
Admit Days Days to Fill Days to Heal 0
Complications Surgery
(p<0.0001) (p=0.04) (p<0.0001) (p=0.01)
Readmits & Readmit Days
10
8.44
8
V.A.C.® Therapy
Readmits, Days

4
Wet-to-Dry
2 1.3
0.15 0.68

0 Source: Page, Jeffery DPM., et al.

Readmits Readmit Days
(p=0.001) Courtesy of KCI, San Antonio, TX 06/04

77
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

78
 ®
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

79
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

80
 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 Organs Vascular

Sources: V.A.C.® Therapy Clinical Guidelines, p.3;

Courtesy of KCI, San Antonio, TX 06/04

81
 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

82
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

83
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

84
 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

85
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

86
 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

87
 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

88
 ®
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

89
 ®
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

90
 ®
Dressings – V.A.C.™ VersaFoam

Polyvinyl alcohol

Small and Large

Source: Advanced Wound Dressings Brochure

Courtesy of KCI, San Antonio, TX 06/04

91
 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

92
 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

93
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
Dressing Application

• Place foam into

wound cavity
• Count pieces of
foam
• Annotate total number
in chart and on drape

95
Dressing Application

• Trim the drape

• Cover foam
• 3-5cm border intact
skin

96
Dressing Application

• Cut 2cm hole in drape and

apply T.R.A.C. Pad™

97
Dressing Application

98
 T.R.A.C. Technology
TM

115
Courtesy of KCI, San Antonio, TX 06/04
Slide 27, Rev 06/04
 V.A.C. Therapy Systems
®

V.A.C.®Classic System V.A.C. A T S

®

System

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

100
 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

101
 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

102
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

103
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
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

105
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

106
 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.

107
 Optimizing Therapy
To help optimize the benefits
of V.A.C.® Therapy, the patient
must:
• Maintain active negative pressure
therapy for 22 of 24 hours per day
• Receive clinical evaluation and
guidance on a regular basis
• Address compromising nutritional
issues
Slide 35, Rev 06/04
And the wound must be:
• Debrided of eschar and hardened
slough
• Free of osteomyelitis, or receiving
current antibiotic treatment
therapy
• Free of malignancy
• Adequately perfused to allow
healing
Source: V.A.C.® Therapy Clinical Guidelines, pp.4-5
Courtesy of KCI, San Antonio, TX 06/04
124
 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

109
Case Studies

• VAC® alone
• With other
modalities

110
 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
 VAC® alone

5 weeks later

Venous stasis ulceration, lateral

malleolus

112
VAC® with Regranex® and Mepitel®

113
VAC® with Regranex® and Promogran®

114
VAC® with Acticoat®

115
VAC® with APC+ with Promogran®

116
VAC® with Apligraf®

2 applications
later

117
VAC® with Promogran®

118
VAC® with Dermagraft®

119
 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

120
VAC® with Oasis®

140
VAC® with skin graft

122
VAC® with skin graft

123
Other Healing
Modalities

Free, Transpositional and Rotation

Flaps

All amenable to VAC® therapy to increase viability

124
Island Flap

125
Rotational Flap

126
Transpositional
Flap

127
 Off-loading of
Site
• Use of total contact casting
• Use of patellar tendon bearing brace

128
 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

129