Transcript COST EFFECTIVE WOUND MANAGEMENT

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: [email protected]
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
“EVIDENCE-BASED MEDICINE IS…
The conscientious, explicit, and judicious use
of current best evidence in making
decisions about the care of individual
patients.” 1
1Sackett
DL et al. Br Med J, 1997; 312:71-77.
Sir Isaac Newton
1642-1727
If I have seen further,
It is by standing upon
The shoulders of giants.
YOU CAN CHOOSE…
CARE FOR WOUNDS
DIAGNOSE,
CARE FOR
WOUND,
PATIENT
PROVIDE
CARE
MORE CARE...
OR
HEAL WOUNDS
using evidence-based practice.
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
How Does EB Wound Care Differ From
Traditional Wound Practice?1
Traditional
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Focus on practice
Parental approach
Clinician oriented
Expert opinion-based
1 Jaeschke
Evidence-Based
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Focus on outcomes
Informed decision
Patient oriented
Science-based
R, Guyatt GH, Meade M. Adv Wound Care 1999; 11(5):214
Doctor's Visit
Traditional
Evidence-Based
Based on the evidence,
•Therapies A or B may help
you achieve your wound
care goals.
"I think you should take
this therapy."
"Be sure you follow the
instructions."
•The risks, benefits and
costs of each therapy are...
•Which would you be most
comfortable using?
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):214-218
2 Gray M. et al. JWOCN 2004; 31(2):53-61.
Benefits Of EB Wound Care
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Reliable, safe patient outcomes
Consistently managed patients
Reduced recurrence
Improved professional reputation
Reduce legal liability
Economically sound outcomes
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/
BRIDGING THE GAP BETWEEN
EVIDENCE AND PRACTICE
INTEGRATING EVIDENCE-BASED
PRINCIPLES INTO WOUND PRACTICE
Implementing EB Principles In Wound
Care Practice
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
Patient-oriented Goal Guides the Action Plan
If the GOAL is...
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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...
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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
Evidence-based (EB)
Action
To Manage Patient and Wound
• Diagnose & correct tissue damage causes
• Optimize wound bed & surrounding skin
• Provide moist healing environment
Diagnose….
Diagnose and correct the cause(s) of tissue
damage!
Chronic wounds require a
multidisciplinary team to diagnose and
correct the cause.
• Contributing factors
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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!
Example EB Principles to Use on Full- and
Partial-thickness Acute Wounds
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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
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. 1998; 25(3):116-122.
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)
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Abrasions (4)
Amputation sites (1)
Biopsy sites (6)
Blisters (1)
Burns (6)
Circumcisions (1)
Epidermolysis bullosa(1)
Excoriations, trauma (1)
Flap survival(1)
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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)
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
Pressure ulcer treatment & prevention guidelines: AHRQ,1 WHS2 and WOCN3
4Kerstein et al. Disease Management Health Outcomes, 2001; 9(11):651-663
EB Venous Ulcer Management1,2,3
• 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 4layer elastic compression
– Elevate limb, flex ankle or walk
– Elastic stockings prevent recurrence
• Manage exudate and dermatitis
• Moist wound environment
1McGuckin
M, et al. Amer J Surgery 2002; 183:132-137.
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
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?
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
1Hopf
H. et al. Wound Rep Regen, 2006; 14: 693-710. (WHS Guideline)
2Kerstein MD. Ostomy/Wound Mgmt 1996; 42(10A Suppl):19S-35S
EB Diabetic Foot Ulcer Management1,2,3
• Diagnose and correct the cause
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–
–
–
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
1Steed
et al. Wound Rep Reg (2006) 14 680–692 (WHS Guideline)
2Crawford et al. WOCN Guideline 3 …Lower extremity neuropathic disease
3Amer Diab Assn Consensus Dev. Conf., Diabetes Care 1999; 22(8):1354-1360.
42Smith J, Thow J. The Diabetic Foot 2003; 6(1):12-16
Consistent, Continuous
Off-loading
One barefoot walk to the bathroom can
undo a week of healing.
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
1Hutchinson
Infection is 5x more likely in
DFU than in non-diabetic
chronic wounds4
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
Moist Environment to Protect, Isolate Wound:
Fewer Infections in Diabetic Neuropathic Ulcers
BOULTON et al.
Percent Clinical Infections
Reported
Wound Rep Reg 1999;7:7-16
6
Retrospective study
• Clinical infections
– diabetic foot ulcers
• Off-load + Dressings:
– Hydrocolloid (HCD)
– Traditional Gauze
6
5
4
3
2.5
2
1
0
Gauze
HCD
Protocols of Care
Moist Environment to Protect, Isolate Wound
Reduces Risk of Infection: All Wounds
Percent Clinical Infections
Reported
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
8
6
7.1
4
4.5
2
2.4
1.3
0
Gauze HCD Foams Films
Protocol
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
Debridement Types
• Surgical/ Sharp
• Enzymatic
• Autolytic
• Mechanical
• Be aware
– Wounds will appear larger after
necrotic tissue is removed
1AHCPR
Guidelines for Tx, Px of Pressure Ulcers
2Smith & Thow The Diabetic Foot, 2003; 6(1):12-16.
3 Romanelli, Wounds, 1997;9:122-126.
4Burgos A et al. Clin Drug Invest. 19(5):357-365)
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
PRESSURE ULCER HEALING
(Full-Thickness, Mean Initial Area 6.3 cm2)
Slow Wound Contraction Warns of Non-Healing
% Contraction
150
100
50
0
*
-50
2
*
4
*
*
*
6
8
10
>12
-100
-150
Weeks of Care
HEALING (N=17)
vanRijswijk L. Decutitus, 1993;6(1):16-21.
NON-HEALING (N=25)
*  <0.01
EB Practice: Pressure Ulcer Healing
Meta-analysis
Proportion of ulcers healed at 12 weeks
70%
60%
61%
51%
48%
50%
40%
30%
20%
N=102
N=281
N= 136
10%
0%
Gauze
HCD D
HCD C
Local Wound Dressing in Protocol of Care
Kerstein MD, et al. Disease Management and Health Outcomes, 2001;9(11),651-663
EB Practice: Venous Ulcer Healing
Meta-analysis
Proportion of ulcers healed at 12 weeks
61%
51%
51%
41%
45%
39%
31%
20%
N=223
N=530
N=130
10%
0%
Gauze
HCD D
Skin Construct
Local Wound Dressing in Protocol with Compression
Kerstein MD, et al. Disease Management and Health Outcomes, 2001;9(11),651-663
Diabetic Neuropathic Foot Ulcers
Perspective: 78% Heal in 10 Weeks With TCC/Hydrocolloid Dressing
Wagner Grade 2-3 Diabetic Foot Ulcer Healing
60
AQ(1)
APLG(2)
REGR (3)
Platelet Releasate
Gauze
Bioengineered Dermis
DRMG(4)
Gauze
0
Placebo
10
RhPDGF BB
20
Gauze
30
Gauze
40
Bioengineered Skin
50
Hydrofiber®
% Healed During 10-20 weeks
70
PR(5)
Protocols of Care Including
(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
Implementing Evidence-Based
Wound Practice
How to Implement EB Wound Practice1
Multidisciplinary wound care team2
Identify practices and outcomes to improve
Facility--make a plan based on:
1.
2.
3.
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4.
5.
6.
7.
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
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.
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
Goals Based on
Patient
Wound
evaluation
Rule out arterial (ABI) Manage exudate
Reduce edema
Heal venous ulcer
Reduce pain
Action plan
Elastic compression
agreeable to patient
Absorbent primary
dressing, moisture
barrier secondary
Patient-reported pain
Ankle circumference
Length, width, depth
Healing time
Evidence-Based
Progress
Measures
Beitz JM, Bates-Jensen B. O/WM, 2001; 47(4):33-40
Implementing Evidence-Based Guidelines
Avoid Pitfalls
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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
Clinical Outcomes
Using Evidence-Based
Protocols of Wound Care
Japan Pressure Ulcer Outcomes Using EB Protocol
Mean PSST Scores
Ohura T, Sanada H, Mino Y.Wounds 2004; 16(5):157-73
35
30
25
29.8
MC/A
TC/A
26.9
TC/NA
22.5
21.9
20
15
10
31.5
15.8
At time of
enrollment
At the end of
study
MCA
improved PU
outcomes at
less than half
the total
(labor +
materials)
cost of TC/NA
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
Validating EB Venous Ulcer Guidelines in US and UK
(McGuckin M. et al. Amer J Surgery 2002; 183:132-137.)
Percent Healed in 12 Weeks
Validation Results (N=40 / Group) (P<0.05)
80%
70%
65%
70%
60%
50%
40%
40%
30%
23%
20%
10%
0%
Pre-Guideline With Guideline Pre-Guideline With Guideline
United States
United Kingdom
Software EB Guidelines in Home Telemedicine
Kobza L, Scheurich A. O/WM . 2000; 46(10):48-53
Telemedicine
Base Station with
validated Solutions®
algorithms
Phone/DSL Line
Network
Patient’s Home
Speaker
video
phone
More Wounds Healed Faster Using EB Practice in
Home Telemedicine
(Kobza L, Scheurich A. Ostomy/Wound Manag. 2000; 46(10):48-53)
Retrospective (n=120)
WEEKS TO HEAL
(% HEALED)
25.0
10%
31%
20.0
15.0
TM + EB Practice (n=76)
58%
36%
43%
57%
34%
55%
56%
10.0
83%
5.0
0.0
Stage II
PU
Stage III Stage IV Venous Diabetic
PU
PU
Ulcer
Foot
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
Depth: Thickness
Partial (N = 134)
Full
(N = 373)
1Bolton
Mean heal time
31 days
62 days
% Healed in 12 weeks
61%
36%
L, McNees P, van Rijswijk L et al. JWOCN 2004; 31(3):65-71
2Rees R. Wound Rep Reg, 1999, 7:141-147.
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
Partial (N = 30)
Full
(N = 124)
Mean + SE heal time
29 + 7 days
57 + 7 days
% Healed in 12 weeks
77%
44%
Bolton L, McNees P, van Rijswijk L et al. Wound healing outcomes using
standardized care JWOCN 2004; 31(3):65-71.
Average Days to Healing or To
Discharge to Family Care
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
1400
(McIsaac C. O/WM 2005 Apr;51(4):54-6, 58, 59 passim. )
1200
Pressure Ulcer
Venous Ulcer
Diabetic Foot Ulcer
Ischemic/Mix Ulcer
Surgical Wound
Burn Wound
Other Wound
1000
800
600
400
200
0
1Numbers
1999
(6)
2000
(3)
2001
(33)
2002
(435)
2003
(250)
in parentheses
are total clients healed
during specified year,
not total receiving care.
Hippocrates 460-400 BCE
Law, Book IV
“There are in fact two
things, science and
opinion;
the former begets
knowledge, the latter
ignorance.”