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EVIDENCE-BASED WOUND CARE Laura Bolton, Ph.D., Adjunct Associate Professor, Dept. of Surgery, Bioengineering Section University of Medicine & Dentistry.

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Presentation on theme: "EVIDENCE-BASED WOUND CARE Laura Bolton, Ph.D., Adjunct Associate Professor, Dept. of Surgery, Bioengineering Section University of Medicine & Dentistry."— Presentation transcript:

1 EVIDENCE-BASED WOUND CARE Laura Bolton, Ph.D., Adjunct Associate Professor, Dept. of Surgery, Bioengineering Section University of Medicine & Dentistry of New Jersey President, BoltonSCI, LLC E-mail: llbolton@gmail.com Laura Bolton, Ph.D., Adjunct Associate Professor, Dept. of Surgery, Bioengineering Section University of Medicine & Dentistry of New Jersey President, BoltonSCI, LLC E-mail: llbolton@gmail.com

2 GOALS 1.Define evidence-based (EB) wound care 2.Describe EB wound care principles and how to integrate them into your wound care practice. 3.Review results reported using EB protocols of wound care 1.Define evidence-based (EB) wound care 2.Describe EB wound care principles and how to integrate them into your wound care practice. 3.Review results reported using EB protocols of wound care

3 “EVIDENCE-BASED MEDICINE IS… The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” 1 1 Sackett DL et al. Br Med J, 1997; 312:71-77.

4 Sir Isaac Newton 1642-1727 If I have seen further, It is by standing upon The shoulders of giants. If I have seen further, It is by standing upon The shoulders of giants.

5 DIAGNOSE, CARE FOR WOUND, PATIENT DIAGNOSE, CARE FOR WOUND, PATIENT PROVIDE CARE MORE CARE... YOU CAN CHOOSE… CARE FOR WOUNDS OR HEAL WOUNDS using evidence-based practice.

6 Scope Of Evidence-Based Wound Care WHO can use EB wound care? –All disciplines: MD, RN, ET, APN, PT, DPM... WHERE –All settings: Home, Hospital, Skilled Care... –All indications: Post-op, traumatic, chronic... HOW –Diagnosis, predicting outcomes and therapy WHAT IS USED –Evidence of both benefits and risks –To derive patient-centered wound outcomes WHO can use EB wound care? –All disciplines: MD, RN, ET, APN, PT, DPM... WHERE –All settings: Home, Hospital, Skilled Care... –All indications: Post-op, traumatic, chronic... HOW –Diagnosis, predicting outcomes and therapy WHAT IS USED –Evidence of both benefits and risks –To derive patient-centered wound outcomes

7 How Does EB Wound Care Differ From Traditional Wound Practice? 1 Traditional Focus on practice Parental approach Clinician oriented Expert opinion-based Traditional Focus on practice Parental approach Clinician oriented Expert opinion-based Evidence-Based Focus on outcomes Informed decision Patient oriented Science-based 1 Jaeschke R, Guyatt GH, Meade M. Adv Wound Care 1999; 11(5):214

8 Doctor's Visit Traditional Evidence-Based "I think you should take this therapy." "Be sure you follow the instructions." "I think you should take this therapy." "Be sure you follow the instructions." Based on the evidence, Therapies A or B may help you achieve your wound care goals. The risks, benefits and costs of each therapy are... Which would you be most comfortable using?

9 HALLMARKS OF GOOD EVIDENCE 1,2 Randomized assignment of patients Independent blinded comparison of treatment effects or comparison to accepted standard Efficacy and safety measured and reported Valid outcomes measured reliably Clinically relevant, patient-centered outcomes Representative, similar patient samples Adequate timing and scope of follow up 1 Jaeschke R et al. Adv Wound Care, 1998; 11(5):214-218 2 Gray M. et al. JWOCN 2004; 31(2):53-61. Randomized assignment of patients Independent blinded comparison of treatment effects or comparison to accepted standard Efficacy and safety measured and reported Valid outcomes measured reliably Clinically relevant, patient-centered outcomes Representative, similar patient samples Adequate timing and scope of follow up 1 Jaeschke R et al. Adv Wound Care, 1998; 11(5):214-218 2 Gray M. et al. JWOCN 2004; 31(2):53-61.

10 Benefits Of EB Wound Care Reliable, safe patient outcomes Consistently managed patients Reduced recurrence Improved professional reputation Reduce legal liability Economically sound outcomes Reliable, safe patient outcomes Consistently managed patients Reduced recurrence Improved professional reputation Reduce legal liability Economically sound outcomes

11 Some EBM Resources: http://www…. Cochrane Initiative –cochrane.org/ McMasters –shef.ac.uk/uni/academic/R-Z/scharr/ triage/index/EBM.htm National Library of Med. (MEDLINE) –ncbi.nlm.nih.gov/PubMed/ National Guideline Clearinghouse –guideline.gov/ Cochrane Initiative –cochrane.org/ McMasters –shef.ac.uk/uni/academic/R-Z/scharr/ triage/index/EBM.htm National Library of Med. (MEDLINE) –ncbi.nlm.nih.gov/PubMed/ National Guideline Clearinghouse –guideline.gov/

12 BRIDGING THE GAP BETWEEN EVIDENCE AND PRACTICE INTEGRATING EVIDENCE-BASED PRINCIPLES INTO WOUND PRACTICE

13 Implementing EB Principles In Wound Care Practice G: Identify patient-oriented GOAL A: Evidence-based ACTION PLAN P: Measure PROGRESS G: Identify patient-oriented GOAL A: Evidence-based ACTION PLAN P: Measure PROGRESS Hermans MHE, Bolton LL, Establishing a skin integrity program. Remington Report, 2001; 9(6) Suppl. 1:6-8

14 Patient-oriented Goal Guides the Action Plan If the GOAL is... Reduce edema Reduce pressure Protect wound Protect skin Minimize pain, odor Manage excess fluid Reduce infection risk Heal the wound Minimize scar If the GOAL is... Reduce edema Reduce pressure Protect wound Protect skin Minimize pain, odor Manage excess fluid Reduce infection risk Heal the wound Minimize scar ACTION plan requires... High multi-layer compression Pressure relief surface or shoe Off-load insensate extremity Moisturizing skin barrier Moisture barrier wound dressing With optional absorbent primary dressing Moisture barrier wound dressing

15 Evidence-based (EB) Action To Manage Patient and Wound Diagnose & correct tissue damage causes Optimize wound bed & surrounding skin Provide moist healing environment Diagnose & correct tissue damage causes Optimize wound bed & surrounding skin Provide moist healing environment

16 Diagnose….

17 Diagnose and correct the cause(s) of tissue damage!

18 Chronic wounds require a multidisciplinary team to diagnose and correct the cause. Contributing factors –Vasculature – Nutrition –Endocrinology –Immune Disorders –Infection –Excessive/Prolonged Pressure/Moisture –Repeated Physical or Chemical Trauma Contributing factors –Vasculature – Nutrition –Endocrinology –Immune Disorders –Infection –Excessive/Prolonged Pressure/Moisture –Repeated Physical or Chemical Trauma The wound is attached to A PATIENT. Local care can’t do this alone!

19 Example EB Principles to Use on Full- and Partial-thickness Acute Wounds If wound is bleeding achieve hemostasis rapidly 1 Cool burned tissue, but avoid hypothermia 2 Minimize time between trauma and surgery 1 Debride necrotic tissue or debris 2,3 –Avoid use of wet-to-dry gauze in debriding 3 Select dressing(s) to meet functional wound needs 4,5 –Maintain hemostasis or moist environment, absorb exudate, debride autolyticallly, isolate/protect wound, minimize pain, odor or bioburden Evaluate and minimize patient-reported pain 2,3 If wound is bleeding achieve hemostasis rapidly 1 Cool burned tissue, but avoid hypothermia 2 Minimize time between trauma and surgery 1 Debride necrotic tissue or debris 2,3 –Avoid use of wet-to-dry gauze in debriding 3 Select dressing(s) to meet functional wound needs 4,5 –Maintain hemostasis or moist environment, absorb exudate, debride autolyticallly, isolate/protect wound, minimize pain, odor or bioburden Evaluate and minimize patient-reported pain 2,3 1 Spahn DR et al. Critical Care 2007; 11(1): 1-22 (EU Guideline) 2 www.health.nsw.gov.au/gmct/burninjury/docs/guidelines_burn_wound_management.pdf (AU Guideline, accessed 2 June 2007) 3 Nat. Inst. for Clin. Excellence. Guidance on the use of debriding agents and specialist wound care clinics for difficult to heal surgical wounds. Tech. Appraisal Guid. #24, April 2001. 4 Harding K et al. Diab Metab Res Rev 2000; 16(Suppl. 1):S47-S50. 5 van Rijswijk L, Beitz J. J. W. O. C. N. 1998; 25(3):116-122.

20 EB Practice for Wound Dressings: MEDLINE Search 4-Jun-2007 Found (N) Controlled Studies Supporting Faster Healing and Reduced Pain, Scarring or Infection Rates using Film or Hydrocolloid than with Non-Barrier Dressings (e.g.Gauze) Abrasions (4) Amputation sites (1) Biopsy sites (6) Blisters (1) Burns (6) Circumcisions (1) Epidermolysis bullosa(1) Excoriations, trauma (1) Flap survival(1) Abrasions (4) Amputation sites (1) Biopsy sites (6) Blisters (1) Burns (6) Circumcisions (1) Epidermolysis bullosa(1) Excoriations, trauma (1) Flap survival(1) Ischemic wounds (1) Hypospadias (1) Laser resurfacing (2) Mohs excisions (1) Pressure ulcers (2) Skin tears (1) Skin graft donor sites (6) Surgical incisions (1) Vein harvest incision site (1) Venous ulcers (2)

21 Example steps in Implementing EB Pressure Ulcer Management 1-4 Correct causes of tissue damage –prolonged pressure, friction, sheer 1-4 –nutritional deficiencies 1-4 Wound bed –Debride necrotic tissue 4 –Treat local or distant infection 2 Protect skin from –excess moisture or dryness 1,3,4 –chemical or physical trauma 1,3,4 Maintain a moist wound environment 1-4 Correct causes of tissue damage –prolonged pressure, friction, sheer 1-4 –nutritional deficiencies 1-4 Wound bed –Debride necrotic tissue 4 –Treat local or distant infection 2 Protect skin from –excess moisture or dryness 1,3,4 –chemical or physical trauma 1,3,4 Maintain a moist wound environment 1-4 Pressure ulcer treatment & prevention guidelines: AHRQ, 1 WHS 2 and WOCN 3 4 Kerstein et al. Disease Management Health Outcomes, 2001; 9(11):651-663

22 EB Venous Ulcer Management 1,2,3 Diagnose and correct the cause –Rule out arterial cause: Ankle/brachial index (ABI) > 0.9 ABI 0.7-0.9 compress with care –Sustained, graduated, high, 2- to 4- layer elastic compression –Elevate limb, flex ankle or walk –Elastic stockings prevent recurrence Manage exudate and dermatitis Moist wound environment Diagnose and correct the cause –Rule out arterial cause: Ankle/brachial index (ABI) > 0.9 ABI 0.7-0.9 compress with care –Sustained, graduated, high, 2- to 4- layer elastic compression –Elevate limb, flex ankle or walk –Elastic stockings prevent recurrence Manage exudate and dermatitis Moist wound environment 1 McGuckin M, et al. Amer J Surgery 2002; 183:132-137. 2 Bolton et al., 2 Bolton et al. Ostomy/Wound Mgmt, 2006; 52(11):32-48 (AAWC Guideline) 3 Kerstein MD et al. Dis. Manage. Health Outcomes, 2001;9(11),651-63

23 Venous ulcers heal as edema declines with sustained, graduated, high compression. Duby et al. Wounds 1993; 5(6): 276-279. Sustained high, graduated compression Compression?

24 EB Action Plan To Manage Arterial or Ischemic Ulcers Diagnose, correct related conditions 1,2 –Peri-wound TcPO 2 < 20 mmHg predicts non-healing 1 –Vascular specialist locate, correct arterial blockage Prompt referral if rest pain and/or gangrene 2 Remove necrotic tissue –limit microorganisms 2 Avoid nicotine 1,2 Diagnose, correct related conditions 1,2 –Peri-wound TcPO 2 < 20 mmHg predicts non-healing 1 –Vascular specialist locate, correct arterial blockage Prompt referral if rest pain and/or gangrene 2 Remove necrotic tissue –limit microorganisms 2 Avoid nicotine 1,2 1 Hopf H. et al. Wound Rep Regen, 2006; 14: 693-710. (WHS Guideline) Kerstein MD. Ostomy/Wound Mgmt 1996; 42(10A Suppl):19S-35S 2 Kerstein MD. Ostomy/Wound Mgmt 1996; 42(10A Suppl):19S-35S

25 EB Diabetic Foot Ulcer Management 1,2,3 Diagnose and correct the cause –Control diabetes (HbA1c < 6.5%) –ABI > 0.9 rules out arterial insufficiency –ABI > 1.3  rigid vessel wall; use great toe –No ABI, use TcPO 2 > 40 mmHg Check for neuropathy –Semmes-Weinstein 10 g (#5.07) fiber –Protect skin and off load Wound/Skin: –Gel debridement speeds DFU healing 4 –No healing progress: suspect infection Moist wound environment 3 Diagnose and correct the cause –Control diabetes (HbA1c < 6.5%) –ABI > 0.9 rules out arterial insufficiency –ABI > 1.3  rigid vessel wall; use great toe –No ABI, use TcPO 2 > 40 mmHg Check for neuropathy –Semmes-Weinstein 10 g (#5.07) fiber –Protect skin and off load Wound/Skin: –Gel debridement speeds DFU healing 4 –No healing progress: suspect infection Moist wound environment 3 1 Steed et al. Wound Rep Reg (2006) 14 680–692 (WHS Guideline) 2 Crawford et al. WOCN Guideline 3 …Lower extremity neuropathic disease 3 Amer Diab Assn Consensus Dev. Conf., Diabetes Care 1999; 22(8):1354-1360. 4 2Smith J, Thow J. The Diabetic Foot 2003; 6(1):12-16

26 Consistent, Continuous Off-loading One barefoot walk to the bathroom can undo a week of healing.

27 Evidence For Minimizing Wound Infections Infection is 5x more likely in DFU than in non-diabetic chronic wounds 4 Passive Mechanisms –Isolate and protect wound 1,2 –Debride necrosis, foreign matter 3 Active Mechanisms 3 –Topical antimicrobial agents –If signs of infection are present, Biopsy or quantitative swab to identify infecting organism Prescribe correct systemic antibiotic Passive Mechanisms –Isolate and protect wound 1,2 –Debride necrosis, foreign matter 3 Active Mechanisms 3 –Topical antimicrobial agents –If signs of infection are present, Biopsy or quantitative swab to identify infecting organism Prescribe correct systemic antibiotic 1 Hutchinson JJ, McGuckin M. Amer J Infec Control 1990; 18(4):257-268. 2 Wilson P, et al. The Pharmaceutical Journal December 17, 1988; 787-788. 3 Steed et al. Wound RepRegen, (2006) 14 680–692 4 Rubinstein, Am. J. Med. 1983; 75(1):161

28 Moist Environment to Protect, Isolate Wound: Fewer Infections in Diabetic Neuropathic Ulcers BOULTON et al. Wound Rep Reg 1999;7:7-16 Retrospective study Clinical infections –diabetic foot ulcers Off-load + Dressings: –Hydrocolloid (HCD) –Traditional Gauze BOULTON et al. Wound Rep Reg 1999;7:7-16 Retrospective study Clinical infections –diabetic foot ulcers Off-load + Dressings: –Hydrocolloid (HCD) –Traditional Gauze Percent Clinical Infections Reported 6 2.5 0 1 2 3 4 5 6 GauzeHCD Protocols of Care

29 Moist Environment to Protect, Isolate Wound Reduces Risk of Infection: All Wounds Hutchinson & McGuckin Amer J Infect Control, 1990; 18:257 Retrospective 30 yr literature review Clinical infections 1085 gauze (all types) 1351 hydrocolloid (HCD) 617 foam dressings 1021 film dressings Hutchinson & McGuckin Amer J Infect Control, 1990; 18:257 Retrospective 30 yr literature review Clinical infections 1085 gauze (all types) 1351 hydrocolloid (HCD) 617 foam dressings 1021 film dressings Percent Clinical Infections Reported HCD 7.1 1.3 2.4 4.5 0 2 4 6 8 GauzeFoamsFilms Protocol

30 EB Practice: Debride Necrotic Tissue 1 Healing efficacy 2 only for autolytic gel debridement –Compared to saline gauze on diabetic foot ulcers Debriding efficacy –Autolytic as fast as enzyme on venous 3 or pressure 4 ulcers Be aware –Wounds will appear larger after necrotic tissue is removed Healing efficacy 2 only for autolytic gel debridement –Compared to saline gauze on diabetic foot ulcers Debriding efficacy –Autolytic as fast as enzyme on venous 3 or pressure 4 ulcers Be aware –Wounds will appear larger after necrotic tissue is removed 1 AHCPR Guidelines for Tx, Px of Pressure Ulcers 2 Smith & Thow The Diabetic Foot, 2003; 6(1):12-16. 3 3 Romanelli, Wounds, 1997;9:122-126. 4 Burgos A et al. Clin Drug Invest. 19(5):357-365) Debridement Types Surgical/ Sharp Enzymatic Autolytic Mechanical Debridement Types Surgical/ Sharp Enzymatic Autolytic Mechanical

31 Implementing EB Wound Care: Measure Progress Toward Goal Why measure? Support care decisions Encourage patient Early warning of: –infection –non-healing (4 wk <20% decrease in wound area) Benchmark outcomes Identify problems Why measure? Support care decisions Encourage patient Early warning of: –infection –non-healing (4 wk <20% decrease in wound area) Benchmark outcomes Identify problems What to Measure Wound dimensions Wound bed –Necrotic tissue –Granulation –Epithelization Exudate Odor Pain

32 PRESSURE ULCER HEALING (Full-Thickness, Mean Initial Area 6.3 cm 2 ) * * * ** vanRijswijk L. Decutitus, *  <0.01 vanRijswijk L. Decutitus, 1993;6(1):16 ‑ 21. *  <0.01

33 EB Practice: Pressure Ulcer Healing Meta-analysis Kerstein MD, et al. Disease Management and Health Outcomes, 2001;9(11),651-663 N=102 N=281 N= 136 N=102 N=281 N= 136

34 EB Practice: Venous Ulcer Healing Meta-analysis Kerstein MD, et al. Disease Management and Health Outcomes, 2001;9(11),651-663 N=223 N=530 N=130

35 Diabetic Neuropathic Foot Ulcers Perspective: 78% Heal in 10 Weeks With TCC/Hydrocolloid Dressing (1) AQUACEL ® Hydrofiber® Piagessi A. et al. Diab Med, 1999:S94 : 20 weeks (2) APLIGRAF® Falanga V. Wounds, 2000;12(5) :42A. 12 weeks (3) REGRANEX® Smiell J. et al. Wound Rep Regen 1999; 7:335: 20 weeks (4) DERMAGRAFT® Pollack R. Wounds 1997;9(1):175. 12weeks (5) PROCUREN® Bentkover JD, Champion AH. Wounds, 1993; 5(4):207-215: 20 weeks Hydrofiber® Gauze Bioengineered Skin Gauze RhPDGF BB Bioengineered Dermis Platelet Releasate Placebo Gauze

36 Implementing Evidence-Based Wound Practice

37 How to Implement EB Wound Practice 1 1.Multidisciplinary wound care team 2 2.Identify practices and outcomes to improve 3.Facility--make a plan based on: –Current and future patients and wounds –Current and projected costs and revenues –Forces to use or overcome 4.Select best EB protocols for your practice 5.Motivate patients, staff and management with feedback 6.Train all involved on protocol use 7.Measure and communicate utilization and outcomes 1.Multidisciplinary wound care team 2 2.Identify practices and outcomes to improve 3.Facility--make a plan based on: –Current and future patients and wounds –Current and projected costs and revenues –Forces to use or overcome 4.Select best EB protocols for your practice 5.Motivate patients, staff and management with feedback 6.Train all involved on protocol use 7.Measure and communicate utilization and outcomes 1 Morrell C. et al. Nurs Stand. 2001 Apr 11-17;15(30):68-73. 2 van Rijswijk L. Amer J. Nursing 2004; 104(2):28-30.

38 Implementing EB Protocols Venous Ulcer Care If expected outcomes not achieved, e.g. little progress in 2-4 weeks, re-evaluate etiology, care Beitz JM, Bates-Jensen B. O/WM, 2001; 47(4):33-40 Example EB VU Protocol PatientWound Goals Based on evaluation Rule out arterial (ABI) Reduce edema Reduce pain Manage exudate Heal venous ulcer Action plan Evidence-Based Elastic compression agreeable to patient Absorbent primary dressing, moisture barrier secondary Progress Measures Patient-reported pain Ankle circumference Length, width, depth Healing time

39 Implementing Evidence-Based Guidelines Avoid Pitfalls Credit protocol only if it was clear cause Use objective benchmarks Listen to what missing data tells you. Listen to and use feedback from –Patients –Staff –Management Credit protocol only if it was clear cause Use objective benchmarks Listen to what missing data tells you. Listen to and use feedback from –Patients –Staff –Management

40 Clinical Outcomes Using Evidence-Based Protocols of Wound Care

41 Japan Pressure Ulcer Outcomes Using EB Protocol Ohura T, Sanada H, Mino Y.Wounds 2004; 16(5):157-73 MC/A TC/A TC/NA 10 15 20 25 30 35 At time of enrollment At the end of study 26.9 31.5 15.8 21.9 MC/A (n=29): modern dressings with a standardized wound management algorithm TC/A (n=34): traditional dressings with a standardized wound management algorithm TC/NA (n=20): traditional dressings without using a standardized wound management algorithm 29.8 22.5 Mean PSST Scores MCA improved PU outcomes at less than half the total (labor + materials) cost of TC/NA

42 Validating EB Venous Ulcer Guidelines in US and UK (McGuckin M. et al. Amer J Surgery 2002; 183:132-137.)

43 Phone/DSL Line Network Speaker video phone Telemedicine Base Station with validated Solutions® algorithms Patient’s Home Software EB Guidelines in Home Telemedicine Kobza L, Scheurich A. O/WM. 2000; 46(10):48-53

44 More Wounds Healed Faster Using EB Practice in Home Telemedicine (Kobza L, Scheurich A. Ostomy/Wound Manag. 2000; 46(10):48-53) 34% 83% 58% 57% 10% 36% 31% 55% 43% 56%

45 Depth: Thickness Mean heal time % Healed in 12 weeks Partial (N = 134) 31 days 61% Full (N = 373) 62 days 36% Pressure Ulcer Real-World Healing Outcomes Using Evidence-Based, Validated Algorithms 507 Patients in Home TM, Long Term Care, Acute Care Clinic 1 Using pressure redistribution, less than 5% gauze dressings Benchmark Best reported RCT results with Rx PDGF: 23% of full-thickness pressure ulcers healed in 16 weeks 2 1 Bolton L, McNees P, van Rijswijk L et al. JWOCN 2004; 31(3):65-71 2 2 Rees R. Wound Rep Reg, 1999, 7:141-147.

46 Venous Ulcer Real-World Healing Outcomes Using Evidence-Based, Validated Algorithms 154 Patients in Home TM, Long Term Care, Acute Care Clinic Using compression and less than 5% gauze dressings Depth: Thickness Mean + SE heal time % Healed in 12 weeks Partial (N = 30) 29 + 7 days 77% Full (N = 124) 57 + 7 days 44% Bolton L, McNees P, van Rijswijk L et al. Wound healing outcomes using standardized care JWOCN 2004; 31(3):65-71.

47 Implementing an adaptation of EB validated wound care guideline in Nova Scotia home care reduced time and costs to healing or discharge to family care 1 1 Numbers in parentheses are total clients healed during specified year, not total receiving care. (McIsaac C. O/WM 2005 Apr;51(4):54-6, 58, 59 passim. )

48 Hippocrates 460-400 BCE Law, Book IV “There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance.”


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