Transcript Identify and address underlying pathology

Legal and Clinical
Considersations for the
Management of Chronic
Wounds
Gerit Mulder DPM, MS
Director Wound Treatment and Research Center
Associate Professor of Surgery and Orthopedics
Division of Trauma, Department of Surgery
University of California San Diego
Objectives
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Provide brief overview of legal
considerations in the treatment of
chronic wounds
Discuss importance of Guidelines for
the treatment of chronic wounds
Present principles of wound
management
Legal Considerations
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Ulcers are one of the top three reasons for
litigation in LTC settings and in the senior
population
New Medicare Guidelines may hold acute
care facilities responsible for the cost of
care related to pressure and other chronic
wounds
Ulcers are frequently cited as the cause of
“unrelated” morbidity and mortality
Primary Causes of Litigation
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Minimal to no patient/family
education on problem and prognosis
Unrealistic goals and prognosis
Poor documentation of care and/or
justification of selected treatment
Purpose of Guidelines
Assist with standardization of care
 Provide recommendations for most
appropriate care
 Decrease morbidity and mortality
associated with diabetic ulcers
 Educate medical community on
recommended practice
 Provide recommendations based on
available clinical and scientific evidence
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Guidelines for The Treatment of
Chronic Wounds
IDSA: Diagnosis and Treatment for Diabetic Foot
Ulcers (CID 2004:39 (1 October) Lipskey et al.
 WHS: Guidelines for the treatment of
diabetic,pressure and vneous ulcers ulcers.
(Wound Rep Reg (2006) 14 680-692
 ADA: Consensus Development Conference on
Diabetic Foot Wound Care (Diabetes Care, Vol 22,
No 8, August 1999).
 NPUACP
 American Venous Forum
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Practice Guidelines:
Considerations for use
Designed “to guide” not finalize treatment
 Are recommendations not requirements
 Generalize treatment – do not tailor care to
individual patients
 Are based on evidence at the time of
publication, therefore require on-going
updates
 Are extensively used as legal references
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Principles of Wound
Management
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Identify and treat infection
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Provide systemic support for wound healing
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Debride necrotic tissue
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Utilize appropriate topical therapy
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Identify and address underlying pathology
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Consider advanced technology
Identify and Treat Infection
Differentiate between contamination,
colonization, and infection
Microbial Progression in
Wounds
Contamination
(host control)
Colonization
(established microbial population, host
control, microbial balance)
Critical Colonization
(established microbial population,
wound not progressing, microbial
imbalance, no signs of infection)
Infection
(microbial control)
Topical antimicrobial agent
Systemic antibiotics &
topical antimicrobial agents
Colonization and Contamination:
The role of topical antimicrobials
Reduce bacterial load
Reduce level of inflammatory
cytokines and MMPs
Reduce risk of colonization
progressing to critical infection
Decrease “strike through” of bacteria
Expedite wound closure
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BIOFILMS
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Growth of large aggregates of cells on a surface
encased within 3-D matrix of extracellular polymer
substance (EPS) produced by sessile bacteria
Extracellular polysaccharide matrix film (glycocalyx)
that may require 50-1000 x MIC of antibiotic*
May be beneficial as with vaginal biofilm- blocks
exogenous pathogens and allows for colonization
resistance
May occur in chronic wounds present for as little as two
months
Bacterial flora does not reflect planktonic bacteria in
wound fluid
(Mertz PM, Wounds 2003)
Diagram of a medical biofilm. (a) Planktonic bacteria can be cleared by antibodies and phagocytes, and are susceptible
to antibiotics. (b) Adherent bacterial cells form biofilms preferentially on inert surfaces, and these sessile communities
are resistant to antibodies, phagocytes, and antibiotics. (c) Phagocytes are attracted to the biofilms. Phagocytosis is
frustrated, but phagocytic enzymes are released. (d) Phagocytic enzymes damage tissue around the biofilm, and
planktonic bacteria are released from the biofilm. Release may cause dissemination and acute infection in neighboring
tissue. (Courtesy, Science, 21 May, 1999, VOL 284)
Obtaining Culture Specimens
Do not routinely culture uninfected
wounds
 Culture performed for identification of
infecting organisms, not diagnosis of
infection
• Diagnosis of infection is based on
clinical exam
 Tissue specimens are preferable to
swabs
 Tissue biopsy or curettage (scraping with
a scalpel blade) are better sources for
culture
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Examples of Skin and Soft
Tissue Infections
Superficial complicated SSI
Dehisced Diabetic Amputation
Superficial MRSA due to Trauma
Deep Diabetic Foot Infection
Microbiology of SSTIs
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Gram-positive aerobes
• Staphylococcus aureus, CNS
• Streptococcus, Enterococci
 Group A – Necrotizing fasciitis
 Group B – Diabetics
Gram-negative aerobes
• Enterobacteriaceae
• Pseudomonas aeruginosa
Anaerobes
• Bacteroides fragilis, B. fragilis group,
Fusobacterium, anaerobic streptococci
Streptococcus
Staphylococcus
Management of Superficial
SSTI
Superficial SSTI
Incision & drainage
(only exception is
cellulites);
Debridement
Risk factors absent
No fever or WBC
D/C Home
F/U 48–72 hr
Risk factors absent
WBC or fever
Risk factors present
No fever or WBC
D/C Home
PO antibiotics
F/U 48–72 hr
D/C=discharge; F/U=follow-up
Itani KMF, et al. Informed Decisions/Clinical Strategies for
Gram-Positive Infections (Accepted, in press, June 2005)
Risk factors present
Fever or WBC
Admit for observation
IV or PO antibiotics
Management of Deep SSTI
Deep SSTI
Incision & drainage
(only exception is cellulitis)
Debridement
Simple
No systemic
symptoms
Complicated or
Patient risk factors or
Systemic symptoms
D/C Home
PO antibiotics
F/U 48–72 hr
Admit
IV or PO antibiotics
D/C=discharge; F/U=follow-up
Itani KMF, et al. Informed Decisions/Clinical Strategies for
Gram-Positive Infections (Accepted, in press, June 2005)
Multi Drug Resistant Oragnisms
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MRSA
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Resistant Pseudomonas
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Extended Spectrum Beta Lactamases
Representative Antimicrobial
Susceptibilities: CA- and HA-MRSA
Oxacillin
HA-MRSA
CA-MRSA
Erythromycin
Antimicrobial
Ciprofloxacin
Clindamycin
Tetracycline
Gentamicin
TMP-SMX
Rifampin
Vancomycin
0
Naimi TS et al. JAMA. 2003;290:2976-2984.
20
40
60
Susceptible (%)
80
100
CNS:
<10%
Epithelial
lining fluid3:
18%
Lung tissue2:
17%–24%
Sternal Bone1:
57%
Heart Valve4:
12%
Vancomycin Penetration
Bone5:
7%–13%
Fat4:
14%
Muscle4:
9%
1. Massias L et al. Antimicrob Agents Chemother. 1992;36:2539-2541. 2. Cruciani M et al. J Antimicrob Chemother.
1996;38:865-869. 3. Lamer C et al. Antimicrob Agents Chemother. 1993;37:281-286. 4. Daschner FD et al. J Antimicrob
Chemother. 1987;19:359-362. 5. Graziani AL et al. Antimicrob Agents Chemother. 1988;32:1320-1322.
CNS1:
70%*
Epithelial
lining fluid4:
450%
Alveolar cells4:
15%
Saliva2:
120%
Linezolid Penetration
Bone3:
40%–60%
Sweat2:
55%
Skin Blister Fluid5:
100%
1. Cottagnound et al. J Antimicrob Chemother. 2000;46:981-985; 2. ZYVOX® (linezolid injection, tablets, and oral suspension)
[package insert]. Kalamazoo, Mich: Pharmacia & Upjohn, a Pfizer Company; revised 2003; 3. Lovering AM et al. J Antimicrob
Chemother. 2002, 50:73-77; 4. Conte JE et al. Antimicrob Agents Chemother. 2002;46:1475-1480; 5. Gee T. Antimicrob
Agents Chemother. 2001;45:1843-1846.
Vancomycin and
Zosyn:Overprescribed for?
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No MRSA
No Pseudomonas (particularly
resistant Pseudomonas)
No osteomyelitis as primary cause of
wound infection
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INVANZ
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(ertapenem sodium):
Indications
INVANZ is indicated for the treatment of patients with the
following moderate to severe infections caused by susceptible
isolates of the designated microorganisms:
• Complicated skin/skin structure infections, including
diabetic foot infections without osteomyelitis, due to
Staphylococcus aureus (methicillin-susceptible isolates only),
Streptococcus agalactiae, Streptococcus pyogenes,
Escherichia coli, Klebsiella pneumoniae, Proteus
mirabilis, Bacteroides fragilis, Peptostreptococcus
species, Porphyromonas asaccharolytica, or Prevotella
bivia. INVANZ has not been studied in diabetic foot
infections with concomitant osteomyelitis.
• Invanz® is not indicated for Pseudomonas
Case: Leg Ulcer
78 yo female
 Wound sustained from OR
gurney upon transfer
 Increasing size and pain
over three month period
 Wound treatment with
compression, topicals, and
antibiotics for MSSA
 Further antibiotic treatment
needed?
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Healed Wound
Surgical Debridement of Infected
Tissue
Principles of Wound
Management

Identify and treat infection

Provide systemic support for wound
healing
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Debride necrotic tissue
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Utilize appropriate topical therapy

Identify and address underlying
pathology
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Consider advanced technology
Nutritional Assessment
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Diet history
Recent weight loss over
15% total body weight
Check laboratory indices
Laboratory Indices
Index
Prealbumin (16-30 mg/dL)
Transferrin (200-400mg/dl)
Albumin (3.3-4.5g/dl)
TLC (1500-3000/mm3)
Severe
Moderate
<5.0
5.0-9.0
<160
<2.5
<900
160-180
2.5-3.0
900-1500
Mild
10-15
180-200
3.0-3.3
1500-1800
Nutritional Support
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30-35 calories/kg/day
1.25-1.5 grams of
protein/kg/day
Vitamin and mineral
supplementation
Control Systemic Conditions
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Diabetes: HbA1c < 7.0%
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Medications
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Altered tissue perfusion
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Smoking
Principles of Wound
Management

Identify and treat infection

Provide systemic support for wound
healing

Debride necrotic tissue

Utilize appropriate topical therapy

Identify and address underlying
pathology

Utilize advanced technology
Rationale for Debridement
Necrotic Tissue:
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Impairs wound healing/causes
a prolonged inflammatory
response
Is a culture medium for
bacteria
Inhibits leukocyte phagocytosis
and subsequent kill
Methods of Debridement
Sharp
Mechanical
Methods of Debridement
Enzymatic
Autolytic
When Not To Debride
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Insufficient
vascular flow
Poor potential for
healing (e.g.
medical status,
medications, etc)
Potential for bone
or deep structure
exposure
Principles of Wound
Management

Identify and treat infection

Provide systemic support for wound
healing

Debride necrotic tissue

Utilize appropriate topical therapy

Identify and address underlying
pathology

Consider advanced technology
Utilize Appropriate Topical
Therapy
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Cleanse the wound
Utilize dressings that maintain
a moist wound environment
Consider topical antimicrobials
for heavy colonization
Antimicrobial Dressings
Cadexomer Iodine
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Composition: 3D starch lattice
formed into spherical microspheres
that trap iodine in lattice-fluid
absorbed, pore size increases, iodine
released
Action: Destabilizes bacterial wall
and disrupts membrane
Silver Compounds
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Antimicrobial agents
All silver products are not the same
Include silver sulfadiazene, silver
nitrate, nanocrystaline silver and
numerous new products
Interaction of Ag+ with thiol groups
in enzymes and proteins plays an
essential role in bacterial inactivation
SEM OF COATING
Cross
Section
Plan View
Basic Rules of Dressing
Selection
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High exudate  absorb
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Low exudate  maintain moisture
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No exudate  add moisture
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Infected  change dressing daily
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Immunosuppressed  change
dressing daily
Principles of Wound
Management

Identify and treat infection

Provide systemic support for wound
healing

Debride necrotic tissue

Utilize appropriate topical therapy

Identify and address underlying
pathology

Consider advanced technology
Identify and Address Underlying
Pathology
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Arterial ulcer  revascularize
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Venous ulcer  compression therapy
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Diabetic foot ulcer  off-weight the
foot/ulcer
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Pressure ulcer  pressure reduction
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Etc., etc., etc.
Infection???
Principles of Wound
Management

Identify and treat infection

Provide systemic support for wound
healing

Debride necrotic tissue

Utilize appropriate topical therapy

Identify and address underlying
pathology

Consider advanced technology
Principles of Wound
Management: Summary
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Identify and treat infection
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Provide systemic support for wound
healing
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Debride necrotic tissue
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Utilize appropriate topical therapy

Identify and address underlying
pathology

Utilize advanced technology
Thank You