Evidenced Based Wound Evidenced Based Wound Care Care Robert S. Kirsner, M.D., PhD Robert S. Kirsner, M.D., PhD Department of Dermatology and Cutaneous Surgery Department of Dermatology and Cutaneous Surgery Department of Epidemiology and Public Health Department of Epidemiology and Public Health University of Miami Miller School of Medicine University of Miami Miller School of Medicine Miami, Florida Miami, Florida
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Evidenced Based Wound CareEvidenced Based Wound Care
Robert S. Kirsner, M.D., PhDRobert S. Kirsner, M.D., PhDDepartment of Dermatology and Cutaneous SurgeryDepartment of Dermatology and Cutaneous Surgery
Department of Epidemiology and Public HealthDepartment of Epidemiology and Public Health
University of Miami Miller School of Medicine University of Miami Miller School of Medicine
Miami, FloridaMiami, Florida
University of Miami/University of Miami/
Jackson Memorial Medical CenterJackson Memorial Medical Center
How Do We Make Decisions About What to How Do We Make Decisions About What to Use in a Wound?Use in a Wound?
Randomized Controlled Trials are the Gold StandardRandomized Controlled Trials are the Gold Standard
What’s The EvidenceWhat’s The Evidence
US Preventative Services Task Force. Guide to Clinical Preventative Services. 1996Gray M, et al. J WOCN 2004;31:53-61
Vacuum Assisted Closure for Pressure Ulcers
Silver dressings for pressure ulcers
What is Evidence Based Medicine?What is Evidence Based Medicine?
The conscientious, explicit and judicious use of The conscientious, explicit and judicious use of current best evidence in making decisions current best evidence in making decisions about the care of individual patientsabout the care of individual patients11
This impliesThis implies An analysis of the strengths and weaknesses An analysis of the strengths and weaknesses of scientific medical studies of scientific medical studies Proper interpretation when communicating Proper interpretation when communicating treatment choices to the patienttreatment choices to the patient
1. Centre for Evidence-Based Medicine1. Centre for Evidence-Based Medicine
Why Do We Need EBM?Why Do We Need EBM?
A clinical practice deemed effective based on A clinical practice deemed effective based on common sense or experience may, in fact, be common sense or experience may, in fact, be ineffective, or even harmfulineffective, or even harmful
Improvements may be for reasons other than Improvements may be for reasons other than the interventionthe intervention
– The placebo effectThe placebo effect– Natural resolution of the conditionNatural resolution of the condition
The proper use of available evidence should The proper use of available evidence should aide (not replace!) clinician training and aide (not replace!) clinician training and experienceexperience
What EBM is NotWhat EBM is Not
‘‘Ivory tower’ medicine confined to academic and Ivory tower’ medicine confined to academic and research centersresearch centers
Beyond the reach of the average practitioner Beyond the reach of the average practitioner ‘‘Cookbook’ medicineCookbook’ medicine
– The use of guidelines and protocols can simplify The use of guidelines and protocols can simplify the EBM process for the average practitionerthe EBM process for the average practitioner
Cost-cutting medicineCost-cutting medicine– The practice of EBM frequently results in The practice of EBM frequently results in
significant cost savings (good medicine is cost-significant cost savings (good medicine is cost-efficient)efficient)
Components of EBMComponents of EBM
Step 1: Ask a question:Step 1: Ask a question:
– Does the use of bioengineered tissue lead Does the use of bioengineered tissue lead to improved healing in patients with diabetic to improved healing in patients with diabetic foot ulcers?foot ulcers?
– What is the treatment for venous ulcers?What is the treatment for venous ulcers?
– Is debridement important in chronic wound Is debridement important in chronic wound care?care?
Components of EBMComponents of EBM
Step 2: Track down the best evidence to answer Step 2: Track down the best evidence to answer that question using:that question using:
– www.pubmed.govwww.pubmed.gov
– www.cochrane.orgwww.cochrane.org
– www.cebm.netwww.cebm.net
– www.ovid.comwww.ovid.com
– www.guideline.govwww.guideline.gov
– Etc., etc., etc.Etc., etc., etc.
Growth Factors With Positive Results in RCTGrowth Factors With Positive Results in RCT
Acute WoundsAcute Wounds
Donor SitesDonor Sites
EGFEGF
GHGH
Burn WoundsBurn WoundsFGFFGF
Punch Biopsy SitesPunch Biopsy Sites
PDGFPDGF
Chronic WoundsChronic Wounds
Venous Leg UlcersVenous Leg Ulcers
GM-CSFGM-CSF
CGRP+VIPCGRP+VIP
Diabetic Foot UlcersDiabetic Foot Ulcers
PDGFPDGF
EGFEGF
NGF (foot ulcers)NGF (foot ulcers)
Components of EBMComponents of EBM
Step 3: Critically evaluate the evidence for its Step 3: Critically evaluate the evidence for its validity, importance, and usefulness in clinical validity, importance, and usefulness in clinical practicepractice
Step 4: Integrate the critical evaluation with Step 4: Integrate the critical evaluation with your clinical expertise and the patient’s your clinical expertise and the patient’s individual problems/needsindividual problems/needs
Is Time an Issue? Is Time an Issue? Read Systematic Reviews!Read Systematic Reviews!
A systematic review is a summary of the medical A systematic review is a summary of the medical literature that uses explicit methods to perform literature that uses explicit methods to perform a thorough literature search and critical a thorough literature search and critical appraisal of individual studies.appraisal of individual studies.
A meta-analysis may be performed as well. This A meta-analysis may be performed as well. This is a systematic review that uses statistical is a systematic review that uses statistical methods to summarize the results.methods to summarize the results.
Level II-2: Level II-2: cohort or case-control cohort or case-control analytic studiesanalytic studies– preferably from more than one center or research grouppreferably from more than one center or research group
Level II-3: Level II-3: multiple time series multiple time series with / without interventionwith / without intervention– Includes dramatic results in uncontrolled trialsIncludes dramatic results in uncontrolled trials
Level III: Level III: Opinions of respected authorities Opinions of respected authorities based on based on
– Clinical experienceClinical experience
– Descriptive studiesDescriptive studies
– Reports of expert committeesReports of expert committees
Strength of Strength of EvidenceEvidence(Wound Healing Society)(Wound Healing Society)
Level I: Meta-analysis or at least two Level I: Meta-analysis or at least two randomized controlled trials (RCT)randomized controlled trials (RCT)
Level II: At least one RCT and at least one Level II: At least one RCT and at least one significant seriessignificant series
Level III: Suggestive data supporting Level III: Suggestive data supporting principle, but lacking meta-analyses, RCT principle, but lacking meta-analyses, RCT or multiple clinical seriesor multiple clinical series
Fast, accessible resource for clinicians to Fast, accessible resource for clinicians to make patient care decisionsmake patient care decisions
Usually the result of multidisciplinary Usually the result of multidisciplinary teamworkteamwork
Released by governmental agencies, Released by governmental agencies, professional organizations, universities, professional organizations, universities, individual authorsindividual authors
May vary in regards to strength of scientific May vary in regards to strength of scientific evidenceevidence
Summary Algorithm for Venous Ulcer Care with Annotations of Available Evidence
Guidelines for the treatment of venous ulcers Robson et al., Wound Repair Regen. 2006;14:649-62
Validation of a Venous Ulcer GuidelineValidation of a Venous Ulcer Guideline
Both UK and US wound care settingsBoth UK and US wound care settings Retrospective pre-guideline group (n=80 pts)Retrospective pre-guideline group (n=80 pts) Prospective guideline treated group (n=80 pts)Prospective guideline treated group (n=80 pts)
• 23% to 70% in the US 23% to 70% in the US • 40% to 65% in the UK40% to 65% in the UK
– Cost decreased Cost decreased • $825 to $113 in the US $825 to $113 in the US • £136 to £78 in the UK£136 to £78 in the UK
Better Outcomes and More Cost-EffectiveBetter Outcomes and More Cost-Effective
McGuckin, M., et al., Validation of venous leg ulcer guidelines in the United States and United McGuckin, M., et al., Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg, 2002. 183(2): p. 132-7.Kingdom. Am J Surg, 2002. 183(2): p. 132-7.
Wound Healing Society GuidelinesWound Healing Society Guidelines
Diagnosis
Gross arterial disease should be ruled out by Gross arterial disease should be ruled out by establishing that pedal pulses are present establishing that pedal pulses are present and/or that the ankle brachial index (ABI) is and/or that the ankle brachial index (ABI) is >0.8.>0.8.
Mixed Arterial and Venous Ulcer
Mixed Arterial and Venous Ulcer
5-year Mortality Rate5-year Mortality Rate
16% 18%26%
38%
86%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
BreastCancer
Hodgkin'sDisease
PAD Colon andRectalCancer
LungCancer
pat
ien
ts,
%
American Cancer Society Facts and Figures 2000.American Cancer Society Facts and Figures 2000.Kempczinski RF, Bernhard VM. Introduction and general considerations. In: Rutherford Kempczinski RF, Bernhard VM. Introduction and general considerations. In: Rutherford
Large Ulcers of Long Duration Difficult to HealLarge Ulcers of Long Duration Difficult to Heal
>5 cm>5 cm22 -- 1 point1 point
>6 months duration >6 months duration -- 1 point1 point
Thus a score or 0 to 2 was assigned to each ulcerThus a score or 0 to 2 was assigned to each ulcer
In the University of Pennsylvania data setIn the University of Pennsylvania data set
93% of patients healed - score of 093% of patients healed - score of 0
65% of patients healed - score of 1 65% of patients healed - score of 1
13% of patients healed - score of 2 13% of patients healed - score of 2 Margolis DJ, Berlin JA, Strom BL: Which venous leg ulcers will heal with limb compression. Margolis DJ, Berlin JA, Strom BL: Which venous leg ulcers will heal with limb compression.
Other Predictors of Healing Other Predictors of Healing Healing rate at 4 weeks predicts Healing rate at 4 weeks predicts
overall healing rate overall healing rate
Initial healing rates of >0.1 Initial healing rates of >0.1 cm/wk correlate with healing cm/wk correlate with healing (40-50%)(40-50%)
Rapid identification of patients Rapid identification of patients who are unlikely to respond to who are unlikely to respond to conventional care allows for conventional care allows for earlier interventions with earlier interventions with advanced therapiesadvanced therapies
When you switch a patient to more advanced When you switch a patient to more advanced therapies, you must ask:therapies, you must ask:
Which patients need this and when to intervene?Which patients need this and when to intervene?
Which product to use? Which product to use?
What is the evidence for the product chosen?What is the evidence for the product chosen?– Level of evidenceLevel of evidence– Strength of evidenceStrength of evidence– Approval typeApproval type– SafetySafety– EfficacyEfficacy
15 randomized controlled trials15 randomized controlled trials Total N=768 patients in the studiesTotal N=768 patients in the studies Compression used in 11 trialsCompression used in 11 trials Treatments:Treatments:
Best Way to Heal VLUs with Grafts?Best Way to Heal VLUs with Grafts?
Jones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of YorkJones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of York
Meta-AnalysisMeta-Analysis
No evidence to indicate STSG is better than Standard of CareNo evidence to indicate STSG is better than Standard of Care
Jones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of YorkJones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of York
Meta-AnalysisMeta-Analysis
Apligraf increases probability of healing compared to Standard of CareApligraf increases probability of healing compared to Standard of Care
Cochrane Collaboration
A bilayered artificial skin (in A bilayered artificial skin (in conjunction with compression conjunction with compression
bandaging), increases the chance of bandaging), increases the chance of healing a venous ulcer compared with healing a venous ulcer compared with compression and a simple dressing.compression and a simple dressing.
Falanga V. Sabolinski M. Falanga V. Sabolinski M. Wound Repair RegenWound Repair Regen. 1999;7:201-207.. 1999;7:201-207.
610 10
32
13
40
19
47
P=.008
P=.001
P=.002
ApligrafApligraf ®® In VLU of >1 Year Duration In VLU of >1 Year Duration
Care of the Diabetic Foot Ulcer
GLOBAL PROJECTIONS FOR THE DIABETES GLOBAL PROJECTIONS FOR THE DIABETES EPIDEMIC: 2003-2025 (millions)EPIDEMIC: 2003-2025 (millions)
25.0 39.759%
25.0 39.759%
10.419.788%
10.419.788%
38.244.216%
38.244.216%
1.11.7
59%
1.11.7
59%
13.6 26.998%
13.6 26.998%
WorldWorld 2003 = 189 million2003 = 189 million 2025 = 324 million2025 = 324 million
Increase 72%Increase 72%
81.8156.191%
81.8156.191%
18.235.997%
18.235.997%
14-20% patients will require a lower extremityamputation ~ 86,000 leg
amputations / year
85% amputations are preceded by a lower
extremity ulcer
15% (2.4 million) develop a foot ulcer during their lifetime
18.2 million diabetics(6.3% U.S. population)798,000 new cases/yr
Diabetic Neuropathic Ulcers
EBM for Diabetic Foot UlcerEBM for Diabetic Foot Ulcer
All patients with diabetes should have annual foot All patients with diabetes should have annual foot exams (at least)exams (at least)
Greater monitoring in at risk patientsGreater monitoring in at risk patients(neuropathy, vascular, history of(neuropathy, vascular, history ofulceration, foot deformities)ulceration, foot deformities)
Ulcers with signs of infection require Ulcers with signs of infection require sharp debridement and deep culture sharp debridement and deep culture
Foot ulcers that are not responding withFoot ulcers that are not responding withappropriate wound care at appropriate wound care at 4 weeks4 weeks, should, shouldbe considered for adjuvant care (growthbe considered for adjuvant care (growthfactors, tissue engineered skin) and reassessedfactors, tissue engineered skin) and reassessed
Boulton AJM, Kirsner RS, Vileikyte L. N Engl J Med. 2004;351:48-55.
Guidelines for the Care of Patients Guidelines for the Care of Patients with Diabetic Foot Ulcerswith Diabetic Foot Ulcers
– American Diabetes AssociationAmerican Diabetes Association
– American College of Foot and Ankle SurgeonsAmerican College of Foot and Ankle Surgeons
– Wound, Ostomy, Continence Nurses SocietyWound, Ostomy, Continence Nurses Society
– American Pharmaceutical AssociationAmerican Pharmaceutical Association
– American Orthopaedic Foot and Ankle SocietyAmerican Orthopaedic Foot and Ankle Society
– International Working Group on the Diabetic FootInternational Working Group on the Diabetic Foot
– Infectious Diseases Society of AmericaInfectious Diseases Society of America
– Wound Healing SocietyWound Healing Society
Protocol for Diabetic Foot Ulcer
Objective evaluation for ischemiaObjective evaluation for ischemia
Rule out osteomyelitisRule out osteomyelitis
Sharp debridementSharp debridement
Moist wound healing Moist wound healing
Off-loadingOff-loading
Amputations in Diabetic Foot InfectionsAmputations in Diabetic Foot Infections
Improved outcomes (healing) with decreased rates of Improved outcomes (healing) with decreased rates of major LEA and reduced LOS through multidisciplinary major LEA and reduced LOS through multidisciplinary team approach and/or Critical Pathwayteam approach and/or Critical Pathway
– Gibbons et al Arch Surg 1993 77% Gibbons et al Arch Surg 1993 77% – Larsson et al Diab Med 1995 78% Larsson et al Diab Med 1995 78% – Crane, Werber JFAS 1999 70% Crane, Werber JFAS 1999 70% – Holstein Diabetes Care 1999 ~80%Holstein Diabetes Care 1999 ~80%– Driver Diabetes Care 2005 Driver Diabetes Care 2005 ~82%~82%
Management Options for Offloading the Patient Management Options for Offloading the Patient With a Plantar UlcerWith a Plantar Ulcer
Conclusion: Surgical debridement and larval Conclusion: Surgical debridement and larval therapy showed no significant benefit in therapy showed no significant benefit in these small trials. Hydrogel; no significant these small trials. Hydrogel; no significant evidenceevidence
The Cochrane Database of Systematic Reviews 2007 Issue 1
HEALING OF DIABETIC NEUROPATHIC FOOT ULCERS HEALING OF DIABETIC NEUROPATHIC FOOT ULCERS RECEIVING STANDARD TREATMENT:RECEIVING STANDARD TREATMENT:
A systematic review of the Control groups ofA systematic review of the Control groups of9 randomized clinical trials9 randomized clinical trials
Endpoints of complete closureEndpoints of complete closure
– At 12 weeks: 4 Control groupsAt 12 weeks: 4 Control groups
– At 20 weeks: 6 Control groupsAt 20 weeks: 6 Control groups– Complete closure in 24% and 31%, at
12 Weeks and 20 Weeks, respectively
Analysis of >26000 Diabetic Neuropathic Foot UlcersAnalysis of >26000 Diabetic Neuropathic Foot Ulcers
30-45% of diabetic foot ulcers heal in a 32 week 30-45% of diabetic foot ulcers heal in a 32 week periodperiod
Diabetes Care 2001;24:483-8Diabetes Care 2001;24:483-8
Wound Healing Trajectories as Predictors of Effectiveness of Therapeutic Agents Wound Healing Trajectories as Predictors of Effectiveness of Therapeutic Agents Robson MC, Hill DP, Woodske ME, Steed DL: Arch Surg 2000;135:773-777.
Protocol for Diabetic Foot Ulcer
Objective evaluation for ischemiaObjective evaluation for ischemia
Rule out osteomyelitisRule out osteomyelitis
Sharp debridementSharp debridement
Moist wound healing Moist wound healing
Off-loadingOff-loading
Adjunctive therapyAdjunctive therapy
FDA-Approved Treatments For DFUFDA-Approved Treatments For DFU
Regranex (1997)Regranex (1997)– PDGF-BBPDGF-BB
Apligraf (2000) Apligraf (2000) – Cultured Keratinocytes and Fibroblasts in Cultured Keratinocytes and Fibroblasts in
collagen matrixcollagen matrix
Dermagraft (2001) Dermagraft (2001) – Fibroblast on Vicryl MeshFibroblast on Vicryl Mesh
Steed DL, the Diabetic Ulcer Study Group; Clinical evaluation of recombinant
human platelet-derived growth factor for the treatment of lower extremity
diabetic ulcers. J Vasc Surg 1995;21:71-81.
Steed DL, the Diabetic Ulcer Study Group; Clinical evaluation of recombinant
human platelet-derived growth factor for the treatment of lower extremity
diabetic ulcers. J Vasc Surg 1995;21:71-81.
Regranex Incidence of Complete Healing of DFU Regranex Incidence of Complete Healing of DFU at 20 Weeksat 20 Weeks
CaseCase
Improved Healing With Tissue Improved Healing With Tissue Engineered Skin for Diabetic UlcersEngineered Skin for Diabetic Ulcers
Apligraf®Apligraf®Dermagraft®Dermagraft®
OR healing 1.7x OR healing 1.7x (p=0.044)(p=0.044)
Diabetes Care 2003;26:1701-5Diabetes Care 2003;26:1701-5 Diabetes Care 2001;24:290-295.Diabetes Care 2001;24:290-295.
OR healing 2.1x OR healing 2.1x (95% CI 1.23-3.74)(95% CI 1.23-3.74)
1818
1414
1010
66
44
22
00
1616
1212
88
PP<.05.<.05.
Veves A, et al. Veves A, et al. Diabetes CareDiabetes Care.. 2001;24:290-5.2001;24:290-5.
% o
f P
atie
nts
% o
f P
atie
nts
Incidence of Osteomyelitis at the Study Ulcer SiteIncidence of Osteomyelitis at the Study Ulcer Site
10.4%10.4%
2.7%2.7%
Lower Incidence of Osteomyelitis Lower Incidence of Osteomyelitis
Reiber GE, Boyko EJ, Smith DG. Lower Reiber GE, Boyko EJ, Smith DG. Lower Extremity Foot Ulcers and Amputations in Diabetes. Ulcers and Amputations in Diabetes. In Diabetes in America, 2nd edition. Bethesda, Md. National Diabetes Data Group, National In Diabetes in America, 2nd edition. Bethesda, Md. National Diabetes Data Group, National Institutes of Health, NIDDK, NIH Publication No. 95-1468, 1995.Institutes of Health, NIDDK, NIH Publication No. 95-1468, 1995.
Evidenced Based Wound CareEvidenced Based Wound Care
ConclusionConclusion
Evidence based wound care uses Evidence based wound care uses techniques to answer a clinical techniques to answer a clinical problem for the betterment of problem for the betterment of