Legal and Clinical Considersations for the Management of Chronic Wounds Gerit Mulder DPM, MS Director Wound Treatment and Research Center Associate Professor

Legal and Clinical Legal and Clinical Considersations for the Considersations for the Management of Chronic Management of Chronic

WoundsWounds

Gerit Mulder DPM, MSGerit Mulder DPM, MSDirector Wound Treatment and Research CenterDirector Wound Treatment and Research CenterAssociate Professor of Surgery and OrthopedicsAssociate Professor of Surgery and Orthopedics

Division of Trauma, Department of SurgeryDivision of Trauma, Department of SurgeryUniversity of California San DiegoUniversity of California San Diego

ObjectivesObjectives

Provide brief overview of legal Provide brief overview of legal considerations in the treatment of considerations in the treatment of chronic woundschronic wounds

Discuss importance of Guidelines for Discuss importance of Guidelines for the treatment of chronic woundsthe treatment of chronic wounds

Present principles of wound Present principles of wound management management

Legal ConsiderationsLegal Considerations

Ulcers are one of the top three reasons for Ulcers are one of the top three reasons for litigation in LTC settings and in the senior litigation in LTC settings and in the senior populationpopulation

New Medicare Guidelines may hold acute New Medicare Guidelines may hold acute care facilities responsible for the cost of care facilities responsible for the cost of care related to pressure and other chronic care related to pressure and other chronic woundswounds

Ulcers are frequently cited as the cause of Ulcers are frequently cited as the cause of “unrelated” morbidity and mortality“unrelated” morbidity and mortality

Primary Causes of LitigationPrimary Causes of Litigation

Minimal to no patient/family Minimal to no patient/family education on problem and prognosiseducation on problem and prognosis

Unrealistic goals and prognosisUnrealistic goals and prognosis Poor documentation of care and/or Poor documentation of care and/or

justification of selected treatmentjustification of selected treatment

Purpose of GuidelinesPurpose of Guidelines

Assist with standardization of careAssist with standardization of careProvide recommendations for most Provide recommendations for most appropriate careappropriate care

Decrease morbidity and mortality Decrease morbidity and mortality associated with diabetic ulcersassociated with diabetic ulcers

Educate medical community on Educate medical community on recommended practicerecommended practice

Provide recommendations based on Provide recommendations based on available clinical and scientific evidenceavailable clinical and scientific evidence

Guidelines for The Treatment of Guidelines for The Treatment of Chronic WoundsChronic Wounds

IDSA: Diagnosis and Treatment for Diabetic Foot IDSA: Diagnosis and Treatment for Diabetic Foot Ulcers (CID 2004:39 (1 October) Lipskey et al.Ulcers (CID 2004:39 (1 October) Lipskey et al.

WHS: Guidelines for the treatment of WHS: Guidelines for the treatment of diabetic,pressure and vneous ulcers ulcers. diabetic,pressure and vneous ulcers ulcers. (Wound Rep Reg (2006) 14 680-692(Wound Rep Reg (2006) 14 680-692

ADA: Consensus Development Conference on ADA: Consensus Development Conference on Diabetic Foot Wound Care (Diabetes Care, Vol 22, Diabetic Foot Wound Care (Diabetes Care, Vol 22, No 8, August 1999).No 8, August 1999).

NPUACPNPUACP American Venous ForumAmerican Venous Forum

Practice Guidelines: Practice Guidelines: Considerations for useConsiderations for use

Designed “to guide” not finalize treatmentDesigned “to guide” not finalize treatmentAre recommendations not requirementsAre recommendations not requirementsGeneralize treatment – do not tailor care to Generalize treatment – do not tailor care to individual patientsindividual patients

Are based on evidence at the time of Are based on evidence at the time of publication, therefore require on-going publication, therefore require on-going updatesupdates

Are extensively used as legal referencesAre extensively used as legal references

Principles of Wound Principles of Wound ManagementManagement

Identify and treat infectionIdentify and treat infection Provide systemic support for wound healingProvide systemic support for wound healing Debride necrotic tissueDebride necrotic tissue Utilize appropriate topical therapyUtilize appropriate topical therapy Identify and address underlying pathologyIdentify and address underlying pathology Consider advanced technologyConsider advanced technology

Identify and Treat InfectionIdentify and Treat Infection

Differentiate between contamination, Differentiate between contamination,

colonization, and infectioncolonization, and infection

Microbial Progression in Microbial Progression in WoundsWounds

Contamination(host control)

Colonization(established microbial population, host

control, microbial balance)

Critical Colonization(established microbial population,wound not progressing, microbialimbalance, no signs of infection)

Topical antimicrobial agent

Infection(microbial control)

Systemic antibiotics &topical antimicrobial agents

Colonization and Contamination: Colonization and Contamination: The role of topical antimicrobialsThe role of topical antimicrobials

Reduce bacterial loadReduce bacterial loadReduce level of inflammatory Reduce level of inflammatory cytokines and MMPscytokines and MMPs

Reduce risk of colonization Reduce risk of colonization progressing to critical infectionprogressing to critical infection

Decrease “strike through” of bacteriaDecrease “strike through” of bacteriaExpedite wound closureExpedite wound closure

BIOFILMSBIOFILMS Growth of large aggregates of cells on a surface encased within Growth of large aggregates of cells on a surface encased within

3-D matrix of extracellular polymer substance (EPS) produced 3-D matrix of extracellular polymer substance (EPS) produced by sessile bacteriaby sessile bacteria

Extracellular polysaccharide matrix film (glycocalyx) that may Extracellular polysaccharide matrix film (glycocalyx) that may require 50-1000 x MIC of antibiotic*require 50-1000 x MIC of antibiotic*

May be beneficial as with vaginal biofilm- blocks exogenous May be beneficial as with vaginal biofilm- blocks exogenous pathogens and allows for colonization resistancepathogens and allows for colonization resistance

May occur in chronic wounds present for as little as two monthsMay occur in chronic wounds present for as little as two months Bacterial flora does not reflect planktonic bacteria in wound Bacterial flora does not reflect planktonic bacteria in wound

fluidfluid

(Mertz PM, Wounds 2003)(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 SpecimensObtaining Culture SpecimensDo not routinely culture uninfected Do not routinely culture uninfected woundswounds

Culture performed for identification of Culture performed for identification of infecting organisms, infecting organisms, not not diagnosis of diagnosis of infectioninfection• Diagnosis of infection is based on Diagnosis of infection is based on

clinical examclinical examTissue specimens are preferable to Tissue specimens are preferable to swabsswabs

Tissue biopsy or curettage (scraping with Tissue biopsy or curettage (scraping with a scalpel blade) are better sources for a scalpel blade) are better sources for cultureculture

Examples of Skin and Soft Examples of Skin and Soft Tissue InfectionsTissue Infections

Superficial complicated SSISuperficial MRSA due to Trauma

Dehisced Diabetic Amputation Deep Diabetic Foot Infection

Andy, couldn't find this slide in any of the slide decks. I remember seeing it at one point, but we must've deleted it at some point along the way. I jsut formatted this manually.

Microbiology of SSTIsMicrobiology of SSTIs

Gram-positive aerobesGram-positive aerobes• Staphylococcus aureus, CNSStaphylococcus aureus, CNS• Streptococcus, EnterococciStreptococcus, Enterococci

Group A – Necrotizing fasciitisGroup A – Necrotizing fasciitis Group B – DiabeticsGroup B – Diabetics

Gram-negative aerobesGram-negative aerobes• EnterobacteriaceaeEnterobacteriaceae• Pseudomonas aeruginosaPseudomonas aeruginosa

AnaerobesAnaerobes• Bacteroides fragilisBacteroides fragilis, B. , B. fragilisfragilis group, group,

FusobacteriumFusobacterium, anaerobic streptococci, anaerobic streptococci

Streptococcus

Staphylococcus

Management of Superficial Management of Superficial SSTISSTI

D/C=discharge; F/U=follow-up

Itani KMF, et al. Informed Decisions/Clinical Strategies for Gram-Positive Infections (Accepted, in press, June 2005)

D/C HomePO antibioticsF/U 48–72 hr

Risk factors absent WBC or fever

Risk factors presentNo fever or WBC

Incision & drainage (only exception is

cellulites);Debridement

Admit for observationIV or PO antibiotics

Risk factors presentFever or WBC

D/C HomeF/U 48–72 hr

Risk factors absentNo fever or WBC

Superficial SSTI

Management of Deep SSTIManagement of Deep SSTI

D/C HomePO antibioticsF/U 48–72 hr

SimpleNo systemic symptoms

AdmitIV or PO antibiotics

Complicated orPatient risk factors orSystemic symptoms

Incision & drainage(only exception is cellulitis)

Debridement

Deep SSTI

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 OragnismsMulti Drug Resistant Oragnisms

MRSAMRSA

Resistant PseudomonasResistant Pseudomonas

Extended Spectrum Beta LactamasesExtended Spectrum Beta Lactamases

Representative Antimicrobial Representative Antimicrobial Susceptibilities: CA- and HA-MRSASusceptibilities: CA- and HA-MRSA

0 20 40 60 80 100

Vancomycin

Rifampin

TMP-SMX

Gentamicin

Tetracycline

Clindamycin

Ciprofloxacin

Erythromycin

Oxacillin

An

tim

icro

bia

l

Susceptible (%)

HA-MRSA

CA-MRSA

Naimi TS et al. JAMA. 2003;290:2976-2984.

BoneBone55::7%–137%–13%%

Vancomycin Penetration

Sternal BoneSternal Bone11::57%57%

Heart ValveHeart Valve44::12%12%

CNS:CNS:<10%<10%

FatFat44: : 14%14%

MuscleMuscle44::9%9%

EpithelialEpitheliallining fluidlining fluid33::

18%18%

Lung tissueLung tissue22::17%–24%17%–24%

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.

Linezolid Penetration

Saliva2:120%

CNS1:70%*

Bone3:40%–60%

Sweat2:55%

Skin Blister Fluid5:100%

Epitheliallining fluid4:

450%

Alveolar cells4:15%

1. Cottagnound et al. 1. Cottagnound et al. J Antimicrob Chemother.J Antimicrob Chemother. 2000;46:981-985; 2. ZYVOX 2000;46:981-985; 2. ZYVOX®® (linezolid injection, tablets, and oral (linezolid injection, tablets, and oral suspension) [package insert]. Kalamazoo, Mich: Pharmacia & Upjohn, a Pfizer Company; revised 2003; 3. Lovering AM et suspension) [package insert]. Kalamazoo, Mich: Pharmacia & Upjohn, a Pfizer Company; revised 2003; 3. Lovering AM et al. al. J Antimicrob ChemotherJ Antimicrob Chemother. 2002, 50:73-77; 4. Conte JE et al. . 2002, 50:73-77; 4. Conte JE et al. Antimicrob Agents ChemotherAntimicrob Agents Chemother. 2002;46:1475-1480; 5. Gee . 2002;46:1475-1480; 5. Gee T. T. Antimicrob Agents ChemotherAntimicrob Agents Chemother. 2001;45:1843-1846.. 2001;45:1843-1846.

Vancomycin and Vancomycin and Zosyn:Overprescribed for?Zosyn:Overprescribed for?

No MRSANo MRSA No Pseudomonas (particularly No Pseudomonas (particularly

resistant Pseudomonas)resistant Pseudomonas) No osteomyelitis as primary cause of No osteomyelitis as primary cause of

wound infectionwound infection

INVANZINVANZ®® (ertapenem sodium): (ertapenem sodium): IndicationsIndications

INVANZ is indicated for the treatment of patients with the INVANZ is indicated for the treatment of patients with the following moderate to severe infections caused by susceptible following moderate to severe infections caused by susceptible isolates of the designated microorganisms:isolates of the designated microorganisms:

• Complicated skin/skin structure infections, including Complicated skin/skin structure infections, including diabetic foot infections without osteomyelitis,diabetic foot infections without osteomyelitis, due to due to Staphylococcus aureus Staphylococcus aureus (methicillin-susceptible isolates only),(methicillin-susceptible isolates only),

Streptococcus agalactiae,Streptococcus agalactiae, Streptococcus pyogenesStreptococcus pyogenes,, Escherichia coliEscherichia coli,, Klebsiella pneumoniae, Proteus Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus mirabilis, Bacteroides fragilis, Peptostreptococcus species, species, Porphyromonas asaccharolytica, Porphyromonas asaccharolytica, or or Prevotella Prevotella bivia. bivia. INVANZ has not been studied in diabetic foot INVANZ has not been studied in diabetic foot infections with concomitant osteomyelitis.infections with concomitant osteomyelitis.

• Invanz® is not indicated for PseudomonasInvanz® is not indicated for Pseudomonas

Case: Leg UlcerCase: Leg Ulcer

78 yo female 78 yo female Wound sustained from OR Wound sustained from OR gurney upon transfergurney upon transfer

Increasing size and pain Increasing size and pain over three month periodover three month period

Wound treatment with Wound treatment with compression, topicals, and compression, topicals, and antibiotics for MSSAantibiotics for MSSA

Further antibiotic treatment Further antibiotic treatment needed?needed?

Healed WoundHealed Wound

Surgical Debridement of Infected Surgical Debridement of Infected TissueTissue



Nutritional AssessmentNutritional Assessment

Diet historyDiet history

Recent weight loss over Recent weight loss over 15% total body weight15% total body weight

Check laboratory indicesCheck laboratory indices

Laboratory IndicesLaboratory Indices

IndexIndex SevereSevere ModerateModerate MildMild

Prealbumin (16-30 mg/dL)Prealbumin (16-30 mg/dL) <5.0 <5.0 5.0-9.0 5.0-9.0 10-15 10-15

Transferrin (200-400mg/dl) <160 160-180Transferrin (200-400mg/dl) <160 160-180 180-200 180-200

Albumin (3.3-4.5g/dl)Albumin (3.3-4.5g/dl) <2.5 2.5-3.0 <2.5 2.5-3.0 3.0-3.3 3.0-3.3

TLC (1500-3000/mmTLC (1500-3000/mm33) <900 900-1500 1500-1800) <900 900-1500 1500-1800

Nutritional SupportNutritional Support

30-35 calories/kg/day30-35 calories/kg/day

1.25-1.5 grams of 1.25-1.5 grams of protein/kg/dayprotein/kg/day

Vitamin and mineral Vitamin and mineral supplementationsupplementation

Control Systemic ConditionsControl Systemic Conditions

Diabetes: HbADiabetes: HbA1c1c < 7.0% < 7.0%

Medications Medications

Altered tissue perfusionAltered tissue perfusion

SmokingSmoking


Identify and treat infectionIdentify and treat infection Provide systemic support for wound healingProvide systemic support for wound healing Debride necrotic tissueDebride necrotic tissue Utilize appropriate topical therapyUtilize appropriate topical therapy Identify and address underlying pathologyIdentify and address underlying pathology Utilize advanced technologyUtilize advanced technology

Rationale for DebridementRationale for DebridementNecrotic Tissue:Necrotic Tissue:

Impairs wound healing/causes a Impairs wound healing/causes a prolonged inflammatory prolonged inflammatory responseresponse

Is a culture medium for bacteriaIs a culture medium for bacteria

Inhibits leukocyte phagocytosis Inhibits leukocyte phagocytosis and subsequent killand subsequent kill

Methods of DebridementMethods of Debridement

Sharp

Mechanical

Methods of DebridementMethods of Debridement

Enzymatic

Autolytic

When Not To DebrideWhen Not To Debride

Insufficient Insufficient vascular flowvascular flow

Poor potential for Poor potential for healing (e.g. healing (e.g. medical status, medical status, medications, etc)medications, etc)

Potential for bone Potential for bone or deep structure or deep structure exposureexposure



Utilize Appropriate Topical Utilize Appropriate Topical TherapyTherapy

Cleanse the woundCleanse the wound

Utilize dressings that maintain a Utilize dressings that maintain a moist wound environmentmoist wound environment

Consider topical antimicrobials Consider topical antimicrobials for heavy colonizationfor heavy colonization

Antimicrobial DressingsAntimicrobial Dressings

Cadexomer IodineCadexomer Iodine

Composition: 3D starch lattice Composition: 3D starch lattice formed into spherical microspheres formed into spherical microspheres that trap iodine in lattice-fluid that trap iodine in lattice-fluid absorbed, pore size increases, iodine absorbed, pore size increases, iodine releasedreleased

Action: Destabilizes bacterial wall Action: Destabilizes bacterial wall and disrupts membraneand disrupts membrane

Silver CompoundsSilver Compounds

Antimicrobial agentsAntimicrobial agents All silver products are not the sameAll silver products are not the same Include silver sulfadiazene, silver Include silver sulfadiazene, silver

nitrate, nanocrystaline silver and nitrate, nanocrystaline silver and numerous new productsnumerous new products

Interaction of Ag+ with thiol groups Interaction of Ag+ with thiol groups in enzymes and proteins plays an in enzymes and proteins plays an essential role in bacterial inactivationessential role in bacterial inactivation

Cross Section

Plan View

SEM OF COATING

Basic Rules of Dressing Basic Rules of Dressing SelectionSelection

High exudate High exudate absorbabsorb Low exudate Low exudate maintain moisturemaintain moisture No exudate No exudate add moistureadd moisture Infected Infected change dressing dailychange dressing daily Immunosuppressed Immunosuppressed change change

dressing dailydressing daily



Identify and Address Underlying Identify and Address Underlying PathologyPathology

Arterial ulcer Arterial ulcer revascularizerevascularize

Venous ulcer Venous ulcer compression therapycompression therapy

Diabetic foot ulcer Diabetic foot ulcer off-weight the off-weight the

foot/ulcerfoot/ulcer

Pressure ulcer Pressure ulcer pressure reductionpressure reduction

Etc., etc., etc.Etc., etc., etc.

Infection???Infection???



Principles of Wound Principles of Wound Management: SummaryManagement: Summary

Identify and treat infectionIdentify and treat infection Provide systemic support for wound healingProvide systemic support for wound healing Debride necrotic tissueDebride necrotic tissue Utilize appropriate topical therapyUtilize appropriate topical therapy Identify and address underlying pathologyIdentify and address underlying pathology Utilize advanced technologyUtilize advanced technology

Thank YouThank You

Documents

Legal and Clinical Considersations for the Management of Chronic Wounds Gerit Mulder DPM, MS Director Wound Treatment and Research Center Associate Professor