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
Thank you Dr. Chua and Professor Song for inviting me Also, thank ConvaTec for supporting my travel to the symposium . Good morning to you all. It is a delight to share with you information on a topic that has such great potential to improve patients’ wound care outcomes.

2. GOALS Define evidence-based (EB) wound care
Describe EB wound care principles and how to integrate them into your wound care practice.
Review results reported using EB protocols of wound care
This lecture will demonstrate how to blend your wound care expertise with the best available wound care evidence, based on clinical controlled research to help your patients benefit from all humanity’s combined wound care knowledge.
First we will (read from slide…)

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
First, we will define EBM for wound care clinical practice.
Evidence-based wound care is wound care based on the best scientific evidence currently available.
The evidence may not be perfect, but you and your patients deserve wound care based on the best currently available scientific evidence.
1Sackett 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.
In practicing evidence-based wound care, one does not throw away valuable earlier opinions and experience.
One supplements expert opinion and experience with the best available scientific evidence.
This enhances the consistency of practice and allows clinicians to improve their wound care outcomes.

5. YOU CAN CHOOSE… CARE FOR WOUNDS
DIAGNOSE,
CARE FOR
WOUND,
PATIENT
PROVIDE CARE
MORE CARE...
OR HEAL WOUNDS using evidence-based practice.
By using evidence-based practice to supplement your expertise, you can move forward from traditional “caring for wounds” to accomplishing the goals of care, for example healing them or relieving wound pain.

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
EB wound care serves all who help patients with wounds
in all settings along the continuum of care from hospital to rehabilitation facility to home.
It can be used to optimize any part of the care process from diagnosis to prognosis (i.e. prediction of results) and therapeutic efficacy or safety…
Your knowledge of evidence of both benefits and risks of any given care modality can help improve patient-centered health-related outcomes of care.

7. How Does EB Wound Care Differ From Traditional Wound Practice?1
Focus on practice
Parental approach
Clinician oriented
Expert opinion-based
Evidence-Based
Focus on outcomes
Informed decision
Patient oriented
Science-based
EBM is more than simply basing care decisions on the best available science. Instead of focusing on the practice of medicine, it focuses on the goal the patient and practitioner agree to attain.
It replaces the traditional approach of the “physician deciding what is best for the patient”
The patient participates in making an informed decision about the choice of care modalities, based on what science there is to support the safety and efficacy of that modality and what the patient can or will tolerate.
1 Jaeschke R, Guyatt GH, Meade M. Adv Wound Care 1999; 11(5):214

8. Doctor's Visit Traditional Evidence-Based
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?
"I think you should take this therapy."
"Be sure you follow the instructions."
A major difference between EBM and traditional medicine is a shift in focus from the physician to patient. The focus in the traditional doctor’s visit is on the physician. Once the history, physical and diagnosis is done, the traditional doctor's visit ends, with the Dr. saying, “ I think you should take this therapy. Be sure you follow the instructions.”
The EB doctor finishes with a clear statement of “Based on the clinical evidence you have A or B options of therapy. He /She will provide the likelihood of a successful outcome with each and the complications of each, with their associated severity. The informed choice of therapy is” patient-centered” (i.e. made with the patient’s input.). You and your patient make the choice together, informed by the best available clinical science.
Instead of ordering patients to comply with a therapy they may not be able to afford or apply, the evidence-based approach invites the patient to participate in making an informed decision about which therapy may work best for him/her and best suits the patient’s situation.

9. HALLMARKS OF GOOD EVIDENCE1,2
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
1Jaeschke R et al. Adv Wound Care, 1998; 11(5):
2 Gray M. et al. JWOCN 2004; 31(2):53-61.
As a wound care professional, you are often the main patient educator, the main communicator of “what works best” (i.e. is most effictive) for your patients helping them decide what is likely to give them the best clinical results, most safely while meeting their quality of life and economic goals.
So you are the one who needs to be able to recognize the best available evidence for that condition.
The hallmarks of good evidence to support evidence-based decision making are listed here.

10. Benefits Of EB Wound Care
Reliable, safe patient outcomes
Consistently managed patients
Reduced recurrence
Improved professional reputation
Reduce legal liability
Economically sound outcomes
While there are obstacles to EB practice, from a practical point of view the benefits outweigh the limitations:
You derive better, more reliable, safer outcomes for your patients.
Practitioners or nurses on different shifts will not undo each others' work
You'll only handle each wound once--heal it fast and prevent recurrence
Your credibility and respect depends on your ability to get results. Your patients will recommend you as a credible, respectable source of wound or ostomy care.
Reimbursement authorities increasingly base their decisions on treatment modalities that have evidence proving they work, so if you use EBM, you will be more likely to be adequately reimbursed for it..

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/
Since the time when scientific method was formalized, humanity has amassed a growing body of evidence on which to base wound and skin care as well as other medical decisions. If you had to wade through all this evidence, it would be quite a task.
The good news is that much of the work of summarizing the evidence has been done for you. Here are several sites where you can find systematic summaries of the evidence.

12. BRIDGING THE GAP BETWEEN EVIDENCE AND PRACTICE INTEGRATING EVIDENCE-BASED PRINCIPLES INTO WOUND PRACTICE
Summarizing, we have learned what EB medicine is, how to recognize it. and that by integrating EB medicine into wound care practice one can improve patient care and outcomes that patients want.
Now we’ll explore how to integrate EBM into wound practice.

13. Implementing EB Principles In Wound Care Practice
G: Identify patient-oriented GOAL
A: Evidence-based ACTION PLAN
P: Measure PROGRESS
There is a simple way to bridge the gap between science and practice and delight your patients, yourself, your colleagues and your management by delivering much-needed Results or Outcomes, not just caring for pressure ulcers, but healing them.
Dr. Michel Hermans and I call it the “GAP” approach.
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
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

15. Evidence-based (EB) Action To Manage Patient and Wound
Diagnose & correct tissue damage causes
Optimize wound bed & surrounding skin
Provide moist healing environment
The evidence I reviewed for you in preparing this lecture can
1. Diagnose and remove the cause or causes of tissue damage
2. Optimize the wound bed and surrounding skin, e.g.
a. remove necrotic tissue or callus,
b. protect surrounding skin from extremes of moisture or dryness, physical or chemical trauma
3. Provide a physiologically moist environment so nature can heal the wound.

16. Diagnose….
It can sometimes be a challenge to diagnose what you are looking at….

17. Diagnose and correct the cause(s) of tissue damage!
But once you know what you are dealing with, the course of action becomes clear.

18. The wound is attached to
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
Many chronic wounds require a multidisciplinary team to evaluate the patient in order to diagnose and correct their cause(s).
For example, leg or foot ulcers may require a vascular consult.
Pressure ulcers often require a nutritionist on their team.
Diabetic foot ulcers require an endocrinology specialist to help control hyperglycemia.
Etc.
It is important to remember that the patient is on the wound care team as well.
Progress can be slow unless the patient participates.
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 rapidly1
Cool burned tissue, but avoid hypothermia2
Minimize time between trauma and surgery1
Debride necrotic tissue or debris2,3
Avoid use of wet-to-dry gauze in debriding3
Select dressing(s) to meet functional wound needs4,5
Maintain hemostasis or moist environment, absorb exudate, debride autolyticallly, isolate/protect wound, minimize pain, odor or bioburden
Evaluate and minimize patient-reported pain2,3
Now we’ll briefly review some ways to optimize the wound and skin and provide an environment for healing in wound care protocols for some of the more common wounds.
These lists of steps, with supporting evidence are not comprehensive. They are only meant to provide examples and references where more detailed protocols can be found.
These are just a few EB principles to apply to acute wounds.
One of the most broadly applicable one is to select the wound dressing based on each wound’s functional needs, such as hemostasis, exudate absorption or maintaining a moist physiological environment.
1Spahn DR et al. Critical Care 2007; 11(1): 1-22 (EU Guideline)
2www.health.nsw.gov.au/gmct/burninjury/docs/guidelines_burn_wound_management.pdf (AU Guideline, accessed 2 June 2007)
3Nat. 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.
4Harding K et al. Diab Metab Res Rev 2000; 16(Suppl. 1):S47-S50.
5van Rijswijk L, Beitz J. J. W. O. C. N ; 25(3):

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)
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)
Abrasions (4)
Amputation sites (1)
Biopsy sites (6)
Blisters (1)
Burns (6)
Circumcisions (1)
Epidermolysis bullosa(1)
Excoriations, trauma (1)
Flap survival(1)
Published evidence supports using moist wound healing on a variety of acute and chronic wounds. So far it has not been sufficient for certain EB websites to endorse moist wound healing with film or hydrocolloid dressings, but clinicians who need to make wound dressing decisions may benefit from knowing that these two kinds of dressings have the best available evidence in controlled studies.

21. Example steps in Implementing EB Pressure Ulcer Management1-4
Correct causes of tissue damage
prolonged pressure, friction, sheer1-4
nutritional deficiencies1-4
Wound bed
Debride necrotic tissue4
Treat local or distant infection2
Protect skin from
excess moisture or dryness1,3,4
chemical or physical trauma1,3,4
Maintain a moist wound environment1-4
For a pressure ulcer the most effective ways of relieving prolonged pressure are alternating pressure mattresses.
Friction and sheer are reduced by gentle patient repositioning.
Evidence-based debridement methods include surgical, autolytic or enzymatic debridement, with no evidence showing that any one of these techniques is superior to the others on any type of wound.
Pressure ulcer treatment & prevention guidelines: AHRQ,1 WHS2 and WOCN3
4Kerstein et al. Disease Management Health Outcomes, 2001; 9(11):

22. EB Venous Ulcer Management1,2,3
Diagnose and correct the cause
Rule out arterial cause:
Ankle/brachial index (ABI) > 0.9
ABI 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
For a venous ulcer remove the cause by aiding venous return using a combination of:
Have the patient elevate the lower leg above the heart for 30 minutes at least three times a day if feasible. More is better
Patient walking or ankle flexes returns venous blood to the heart by exercising the calf muscle pump. This works only if patients can flex their ankles.
Sustained, graduated high compression of the lower leg is the cornerstone of venous ulcer care.
Sustained means the compression works continuously as long as the compression remains in place
Graduated means there is more compression at the ankle than there is at the knee
High compression means mmHg at the ankle declining to mmHg compression at the infra-patellar notch.
Note: if the patient cannot flex his or her ankle, elastic compression is needed to compensate for lack of the calf muscle pump.
Some compression wraps have indicators for the right amount of stretch on application to deliver high compression and the contours of the leg and LaPlace’s law usually help assure that there will be more compression applied to each square cm of skin surface at the ankle because it is narrower.
Initially, venous ulcers have much fluid as much of the edema in the lower leg flows out through the ulcer, so absorbent primary dressings may be required under a moisture retentive secondary dressing to seal fluid over the wound protecting the surrounding skin and maintaining a moist wound environment. The pruritic (itchy) scaly or weeping venous dermatitis will decline as the edema diminishes. Be aware that it will return if the patient stands in place long enough for edema to accumulate and re-start the cycle of inflammation.
1McGuckin M, et al. Amer J Surgery 2002; 183:
2Bolton et al. Ostomy/Wound Mgmt , 2006; 52(11):32-48 (AAWC Guideline)
3Kerstein MD et al. Dis. Manage. Health Outcomes, 2001;9(11),651-63

23. Sustained high, graduated
Venous ulcers heal as edema declines with sustained, graduated, high compression. Duby et al. Wounds 1993; 5(6):
Sustained high, graduated
compression
Compression?
Patients with venous insufficiency experience edema so severe that it swells local capillaries shut so that they cannot deliver oxygen and nutrients to the cells. The cells struggle to survive, and if they fail, venous dermatitis occurs, ultimately resulting in a venous ulcer if the swelling is not alleviated. Duby and colleagues showed that venous ulcers heal as the edema declines, most efficiently with sustained graduated high compression. If your patient returns to the clinic looking like the top right picture, you know they received the compression you meant them to have. So-called “Compression” in the bottom picture is wasting your time and theirs.

24. EB Action Plan To Manage Arterial or Ischemic Ulcers
Diagnose, correct related conditions1,2
Peri-wound TcPO2 < 20 mmHg predicts non-healing1
Vascular specialist locate, correct arterial blockage
Prompt referral if rest pain and/or gangrene2
Remove necrotic tissue
limit microorganisms2
Avoid nicotine1,2
For arterial or ischemic ulcers removing the cause usually means correcting the vascular problem, for example with self-expanding stents or balloon angioplasty or vascular reconstruction appropriate to correct stenosis or blockage identified in the vascular lab.
1Hopf H. et al. Wound Rep Regen, 2006; 14: (WHS Guideline)
2Kerstein MD. Ostomy/Wound Mgmt 1996; 42(10A Suppl):19S-35S

25. EB Diabetic Foot Ulcer Management1,2,3
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 TcPO2 > 40 mmHg
Check for neuropathy
Semmes-Weinstein 10 g (#5.07) fiber
Protect skin and off load
Wound/Skin:
Gel debridement speeds DFU healing4
No healing progress: suspect infection
Moist wound environment3
Examples of evidence-based diabetic foot ulcer management include:
control diabetes with diet, exercise and pharmaceutical agents if needed. Glycosylated hemoglobin provides a reliable measure of blood sugar.
As with venous ulcers, rule out arterial insufficiency. The Ankle-to-brachial index (ABI) may not work if vascular walls are rigid. In this case you may choose to do toe-to-brachial index (0.7 or more indicates adequate arterial circulation) or use a transcutaneous partial pressure of oxygen (TcPO2) of more than 40 millimeters of mercury (mmHg) to indicate adequate arterial circulation.
Neuropathy, resulting in lack of protective sensation is the most common condition associated with diabetic foot ulcers, so check foot sensation with a 10 gram (number 5.07) Semmes-Weinstein monofilament fiber
consistent 24/7 off loading, and
preventing infection, because the WBCs that fight infection don’t function as efficiently in a high glucose environment and glycosylated hemoglobin delivers less oxygen to the peripheral tissue where it plays a key role in killing organisms via superoxide metabolism.
1Steed et al. Wound Rep Reg (2006) –692 (WHS Guideline)
2Crawford et al. WOCN Guideline 3 …Lower extremity neuropathic disease
3Amer Diab Assn Consensus Dev. Conf., Diabetes Care 1999; 22(8):
42Smith J, Thow J. The Diabetic Foot 2003; 6(1):12-16

26. Consistent, Continuous Off-loading
Consistency in off-loading , for example with the total contact cast shown here on the right or similar non-removable device, is a key to healing diabetic foot ulcers.
A barefoot walk to the bathroom can undo a week’s worth of healing.
One barefoot walk to the bathroom can
undo a week of healing.

27. Evidence For Minimizing Wound Infections
Passive Mechanisms
Isolate and protect wound 1,2
Debride necrosis, foreign matter3
Active Mechanisms3
Topical antimicrobial agents
If signs of infection are present,
Biopsy or quantitative swab to identify infecting organism
Prescribe correct systemic antibiotic
Infection is 5x more likely in DFU than in non-diabetic chronic wounds4
We’ll address wound infection here because diabetic foot ulcers are at high risk of infection, due to impaired function of the host immune cells. In fact, Rubenstein reported in 1983 that infection is 5 times more likely in DFU than in non-diabetic chronic wounds. However, these principles apply to all types of infected wounds.
Passive mechanisms that minimize wound infections include isolating and protecting wounds. For example during an outbreak of Methycillin-resistant Staphylococcus aureus (MRSA) at their United Kingdom hospital, isolation rooms were all being used, so Wilson and Dunn isolated MRSA-contaminated venous ulcers by dressing them with a hydrocolloid dressing, while patients stayed in ordinary hospital rooms. The MRSA disappeared as the wounds healed and the patients were discharged.
Based on published evidence, there is no point in culturing a wound unless one or more of the clinical signs of infection are present:
erythema (seen here at 12 o’clock at the wound rim)
edema
purulent exudate (seen here on the dressing)
unusual odor--if you could smell this grape-sweet Pseudomonas aeruginosa in this wound you would suspect infection
unexplained fever
Unexplained failure to heal
friable granulation tissue (i.e. that bleeds easily)
If any of these signals of infection are present, then either a
1Hutchinson JJ, McGuckin M. Amer J Infec Control 1990; 18(4):
2 Wilson P, et al. The Pharmaceutical Journal December 17, 1988;
3 Steed et al. Wound RepRegen, (2006) –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
Percent Clinical Infections
Reported 6
2.5 1 2 3 4 5
Gauze
HCD
Protocols of Care
As an example of the evidence for moist environments linked to fewer infections, in a retrospective review from Jan 1990 to June 1992 of patients attending their diabetic foot ulcer clinic in Manchester England, Boulton and colleagues reported significantly (<0.05) fewer infections of the 107 diabetic neuropathic foot ulcers which had been dressed with a hydrocolloid dressing (2.5%) than in the 143 dressed only with gauze (6%). All patients received proper off-loading with a total contact cast.
These researchers reported 84% to 89% healing during a mean of 14 weeks for appropriately off-loaded neuropathic foot ulcers in patients with non-insulin dependent diabetes mellitus or in patients with insulin-dependent diabetes mellitus, respectively.

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
Percent Clinical Infections
Reported
7.1
1.3
2.4
4.5 2 4 6 8
Gauze
Foams
Films
Protocol
Hutchinson and McGuckin reported similar effects in a meta-analysis of evidence reporting clinical infections on all chronic and acute wounds up to 1990, with hydrocolloid dressed wounds reporting a 1.3% infection rate and wounds dressed with all types of impregnated or dry gauze dressings reporting a 7.1% infection rate.
HCD

30. EB Practice: Debride Necrotic Tissue1
Healing efficacy2 only for autolytic gel debridement
Compared to saline gauze on diabetic foot ulcers
Debriding efficacy
Autolytic as fast as enzyme on venous3 or pressure4 ulcers
Be aware
Wounds will appear larger after necrotic tissue is removed
Debridement Types
Surgical/ Sharp
Enzymatic
Autolytic
Mechanical
1AHCPR Guidelines for Tx, Px of Pressure Ulcers
2Smith & Thow The Diabetic Foot, 2003; 6(1):12-16.
3 Romanelli, Wounds, 1997;9:
4Burgos A et al. Clin Drug Invest. 19(5): )

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
What to Measure
Wound dimensions
Wound bed
Necrotic tissue
Granulation
Epithelization
Exudate
Odor
Pain
Once you have used evidence-based patient and wound assessment to identify the Goals of care, applied research-based Action plans or Algorithms to meet those goals of care, now its time to reap your rewards and measure the Progress toward the goal! You can use these results to encourage your patients, support your care decisions and convince authorities to allow you to do quality wound care.
And because there will always be some patients who offer special challenges, it will help you identify their problems early before they become catastrophes. If a wound does not show significant healing it is very likely NOT on the path toward healing.

32. PRESSURE ULCER HEALING (Full-Thickness, Mean Initial Area 6.3 cm2)* * * * *
For example, van Rijswijk found that if pressure ulcers don’t decline in area at least 20% during the first 2 weeks of care, they are unlikely to heal
vanRijswijk L. Decutitus, 1993;6(1):16‑ *  <0.01

33. EB Practice: Pressure Ulcer Healing Meta-analysis
N= N= N= 136
By measuring progress, you can establish benchmarks for what to expect in healing wounds.
For example, Kerstein and colleagues published a meta-analysis of the literature measuring pressure and venous ulcer healing rates and found three dressings with evidence on more than 100 pressure ulcers, the number considered adequate to draw conclusions. They reported that 61% of 281 pressure ulcers healed in 12 weeks when dressed with one hydrocolloid dressing compared with 51% when dressed with gauze or 48% with another hydrocolloid dressing.
Kerstein MD, et al. Disease Management and Health Outcomes, 2001;9(11),

34. EB Practice: Venous Ulcer Healing Meta-analysis
N= N= N=130
On venous ulcers Kerstein and colleagues found that most ulcers healed at 12 weeks when the wound was dressed with a hydrocolloid dressing.
Kerstein MD, et al. Disease Management and Health Outcomes, 2001;9(11),

35. Diabetic Neuropathic Foot Ulcers Perspective: 78% Heal in 10 Weeks With TCC/Hydrocolloid Dressing
Bioengineered Dermis
Bioengineered Skin
Platelet Releasate
Hydrofiber®
RhPDGF BB
Gauze
Placebo
The best clinical benchmark for healing results we could find for Wagner grade 2-3 diabetic neuropathic ulcer healing were reported by Laing, in 1994, with 78% healing in 10 weeks or less using standard care with a total contact cast (TCC) and DuoDERM hydrocolloid dressing on the ulcer.
Platelet releasate reported nearly 60% healed in 20 weeks.
Apligraf 55% healed in 12 weeks,
Dermagraft 51% healed in 12 weeks and
Regranex best reported outcome was 48% healed in 20 weeks.
Hyalofill® healed 62% of recalcitrand diabetic foot ulcers in 13 weeks. (Small trial only 22 patients. A much larger trial is in progress.
Gauze
Gauze
Gauze
(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): weeks
(5) PROCUREN® Bentkover JD, Champion AH. Wounds, 1993; 5(4): : 20 weeks

36. Implementing Evidence-Based Wound Practice
You will use these benchmarks for healing times if you plan to implement EB practice.

37. How to Implement EB Wound Practice1
Multidisciplinary wound care team2
Identify practices and outcomes to improve
Facility--make a plan based on:
Current and future patients and wounds
Current and projected costs and revenues
Forces to use or overcome
Select best EB protocols for your practice
Motivate patients, staff and management with feedback
Train all involved on protocol use
Measure and communicate utilization and outcomes
Evidence reports that wounds fare better in the hands of a multidisciplinary team, and you’ll need their help as you implement EB wound practice. The first question your multidisciplinary wound care team will ask is “How is our facility doing in wound care? Are we matching published benchmarks for healing times?”
Have your team identify a commonly treated wound that is falling short of published outcomes for that etiology/type of wound.
Find out what others are doing to improve their results and write it into a protocol of care.
While your team is doing this, evaluate your facility for projected costs and revenues for this type of wound and which individuals on staff or management are likely to resist using the new protocol and why. Learn how to overcome their objections.
Motivate staff and management by showing how it benefits them and the patients you all serve.
Have respected “champions” for the new protocol train all involved on its use.
Frequently and regularly measure progress in training, protocol implementation and results.
Publish results. This will add to everyone’s satisfaction and emphasize your facility’s leadership in helping patients.
1 Morrell C. et al. Nurs Stand 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
Example EB VU Protocol
Patient
Wound
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
Here is an example of an evidence-based protocol of care that your multi-disciplinary team might implement.
Beitz JM, Bates-Jensen B. O/WM, 2001; 47(4):33-40

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
Here are some pitfalls to avoid. (Read from slide)

40. Clinical Outcomes Using Evidence-Based Protocols of Wound Care
Now we’ll review clinical outcomes published by those who have implemented EB clinical protocols in real-world clinical facilities.

41. Japan Pressure Ulcer Outcomes Using EB Protocol
Ohura T, Sanada H, Mino Y.Wounds 2004; 16(5):157-73
Mean PSST Scores 35
31.5
29.8
MC/A
TC/A
TC/NA 30
26.9 25
22.5
MCA improved PU
outcomes at less than half the total (labor + materials) cost of TC/NA
21.9 20 15
In a prospective controlled study, Ohura and colleagues implemented three protocols of care: (1) modern wound care within a standardized EB algorithm or protocol; (2) traditional care with gauze dressings within a standardized algorithm; or (3) traditional care with no algorithm.
They reported that modern dressings within a standardized wound management algorithm healed more ulcers and improved mean Prsssure Sore Status Tool (PSST) scores while reducing by half the total (labor and materials) costs of pressure ulcer compared to gauze-based care with or without a standardized algorithm.
15.8 10
At time of
enrollment
At the end of
study
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

42. Validating EB Venous Ulcer Guidelines in US and UK (McGuckin M. et al
Validating EB Venous Ulcer Guidelines in US and UK (McGuckin M. et al. Amer J Surgery 2002; 183: )
When Dr. Maryanne McGuckin implemented evidence-based venous ulcer guidelines on 40 patients with venous ulcers in two parallel prospective studies in the United States and United Kingdom, a significantly greater percent of patients healed during 12 weeks than had done so historically based on chart reviews of patients in the same clinics before implementing the EB protocol.

43. Software EB Guidelines in Home Telemedicine
Kobza L, Scheurich A. O/WM ; 46(10):48-53
Telemedicine
Base Station with
validated Solutions®
algorithms
Phone/DSL Line
Network
Patient’s Home
In a study implementing EB protocols in home telemedicine, less expert remote home care nurses in 5 Chicago, Illinois, agencies sent images of home care patients’ wounds back to an expert WOCN nurse using a validated wound care algorithm at “Wound Care Central”,
Speaker
video
phone

44. More Wounds Healed Faster Using EB Practice in Home Telemedicine (Kobza L, Scheurich A. Ostomy/Wound Manag. 2000; 46(10):48-53)
10%
31%
58%
36%
43%
57%
34%
56%
55%
Laura Kobza and Ann Scheurich reported significantly faster healing times for all types of chronic wounds in their home care clients practices while significantly reducing the number of home care visits required to heal each wound.
83%

45. Pressure Ulcer Real-World Healing Outcomes Using Evidence-Based, Validated Algorithms
507 Patients in Home TM, Long Term Care, Acute Care Clinic1
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 weeks2
Using a similar protocol of care to Kobza et al., in a wider variety of settings, with appropriate pressure redistribution and less than 5% gauze dressings, full-thickness pressure ulcers like this one, healed in a mean of 62 days, or in half that time if they were managed early, before they reached the full-thickness stage.
Moreover, a greater proportion of ulcers were reported healed in a shorter amount of time using these simple evidence-based protocols of care, than the best results reported using topical growth factors.
Depth: Thickness Mean heal time % Healed in 12 weeks
Partial (N = 134) days %
Full (N = 373) days %
1Bolton L, McNees P, van Rijswijk L et al. JWOCN 2004; 31(3):65-71
2Rees R. Wound Rep Reg, 1999, 7:

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
In the same real-world cohort study, we saw similar results for venous ulcers, with 77% of partial thickness venous ulcers healing in a mean of 29 days and 44% of full-thickness venous ulcers healing in a mean of 57 days using sustained graduated elastic multi-layer compression and less than 5% gauze dressings.
Depth: Thickness Mean + SE heal time % Healed in 12 weeks
Partial (N = 30) days %
Full (N = 124) days %
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 care1
(McIsaac C. O/WM 2005 Apr;51(4):54-6, 58, 59 passim. )
Corrine McIsaac and the Nova Scotia provincial wound care committee implemented an adaptation of these same evidence-based guidelines to improve home wound care healing time by more than 90% while saving more than $3000 per patient healed.
1Numbers in parentheses are total clients healed during specified year,
not total receiving care.

48. Hippocrates 460-400 BCE Law, Book IV
“There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance.”
In conclusion, Hippocrates taught his students to apply scientific principles to clinical practice. Perhaps it is time to follow his advice.
Those who have done so applying evidence-based wound care protocols or algorithms to supplement their clinical experience have benefited their patients with improved outcomes and fewer complications, while saving money and resources.