iccp-wound care literature review
TRANSCRIPT
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2009
Integrated Client Care
Project
WOUND CARE BEST PRACTICES
AND OUTCOMES: A REVIEW OFTHE LITERATURE
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Contents
1. INTRODUCTION .................................................................................................................................... 4
2. SUMMARY ............................................................................................................................................ 4
i. Venous Ulcer Care: ........................................................................................................................... 4
ii. Diabetic Foot Ulcer Care:.................................................................................................................. 4
iii. Outcomes/Outcome Measurements:............................................................................................... 5
3. VENOUS LEG ULCERS ............................................................................................................................ 5
Synopsis: ................................................................................................................................................... 5
3.1. A Transprofessional Comprehensive Assessment Model for Persons with Lower Extremity
Leg and Foot Ulcers,by Kevin Woo, Afsaneh Alavi, Mariam Botros, Laura Lee Kozosy, Marjorie
Fierheller, Kadhine Wiltshire and R. Gary Sibbald. ................................................................................... 6
3.2. Assessment and Management of Venous Leg Ulcers,an RNAO Nursing Best Practice
Guideline ................................................................................................................................................... 7
3.3. Best Practices for the Prevention and Treatment of Venous Leg Ulcers,by Brian Kunimoto,
Maureen Cooling, Wayne Gulliver, Pamela Houghton, Heather Orsted and Gary Sibbald. ..................... 9
3.4. Best Practice Recommendations for the Prevention and Treatment of Venous Leg Ulcers:
Update 2006,by Cathy Burrows, Rob Miller, Debbie Townsend, Ritchie Bellefontaine, Gerald
MacKean, Heather Orsted and David Keast. ............................................................................................. 9
3.5. Compression for Preventing Recurrence of Venous Leg Ulcers (Review),by E Andrea
Nelson, Sally EM Bell-Syer and Nicky A Cullum. ..................................................................................... 11
3.6. Summary Algorithm for Venous Ulcer Care with Annotations of Available Evidence,
Association for Advancement of Wound Care (AAWC), 2005. ............................................................... 12
3.7. Management and Prevention of Venous Leg Ulcers : A Literature Guided Approach,by
Brian T. Kunimoto ................................................................................................................................... 13
4. DIABETIC FOOT ULCERS ...................................................................................................................... 14
Synopsis: ................................................................................................................................................. 14
4.1. Best Practices for the Prevention, Diagnosis and Treatment of Diabetic Foot Ulcers,by
Shane Inlow, Heather Orsted and Gary Sibbald ..................................................................................... 15
4.2. Evaluation and Treatment of Diabetic Foot Ulcers,by Ingrid Kruse and Steven Edelman.... 16
4.3. Diabetic Foot Ulcers: Pathogenesis and Management,by Robert Frykberg ........................ 17
4.4. Diabetic Foot Ulcers,by Kyle Goettl, Christine Pearson and Mariam Botros ........................ 18
4.5. Assessment and Management of Foot Ulcers for People with Diabetes,RNAO Best Practice
Document................................................................................................................................................ 19
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1. INTRODUCTIONThe purpose of this review is to provide an overview and summary of clinical evidence and opinions on
best practices and outcome measures in the area of wound care. More specifically, this report focuses
on venous leg and diabetic foot ulcers. While the literature search also encompassed post-surgical
wounds, it found that the existence of evidence and best practice guidelines specific to their treatment
is not yet developed to the extent that it is for the above two wound types. In addition, articles
discussing the kinds of outcome measurements to be used in wound care and the importance of
properly recording and analysing outcome data are included. The majority of articles reviewed below
were of Canadian and U.S. origins and content, although there are references to studies done in the UK
and elsewhere.
2. SUMMARYThe key patterns of opinion and evidence that emerged from the review of best practice literature are:
i. Venous Ulcer Care:A team, interdisciplinary approach is necessary for the optimal treatment and
achievement of best results.
In terms of caring for the local wound itself, best practice indicates that the key areas
for clinicians to focus on are debridement, infection control and compression (through
bandages or stockings).
Patient involvement in the healing and prevention process is underscored by a number
of authors and studies. This includes compliance with prescribed regimens as well as
implementing lifestyle changes where necessary.ii. Diabetic Foot Ulcer Care:
Similarly to the venous leg ulcers, diabetic foot ulcers are complex and require
multidisciplinary care. Foot ulcers in people with diabetes and the complications arising
from them are the leading cause of lower extremities amputations, which adds to the
impetus and urgency for preventing and properly treating such wounds.
Prevention and screening, especially for people with past history of foot ulcers, is
stressed as being of extreme importance. Experts and recommended guidelines advise
that it is crucially important that patients be monitored for loss of protective sensation
in their lower extremities (the usually suggested method is by way of applying a
monofilament test to the patients feet).Local wound care in the case of diabetic foot ulcers should encompass three key
components: debridement, infection control, pressure offloading (through appropriate
footwear or casts).
As in the case of venous leg ulcers, experts stress the importance of patient involvement
for the successful treatment and prevention of diabetic foot ulcers.
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iii. Outcomes/Outcome Measurements:The consensus among experts and across studies is that accurate and ongoing
measurement of relevant outcomes is of pivotal importance for choosing and adjusting
treatment options and achieving end results.
Wound surface area (accurately determined) as well as wound depth and extent of
tissue involvement emerged as the two crucial measures to be monitored.
Other indicators such as increase/reduction of edema and exudates from the wound are
also important in the monitoring of the healing process.
One article pointed out the lack of a comprehensive, easy to use tool for measuring
healing progress for venous leg ulcers.
Some recommended tools for wound outcome and healing measurement were the
Bates-Jensen Wound Assessment Tool and the PUSH tooloriginally designed for
assessing pressure ulcerswhich one author argues can be used for assessment of
venous leg ulcers.
3. VENOUS LEG ULCERSSynopsis:
# of Articles Reviewed 7
Types of
articles
The articles reviewed in this section include various best practice guideline
documents, conference summaries and expert clinicians opinions concerned with
the treatment and prevention of venous leg ulcers.
Both Canadian and U.S. guidelines were included in this review.
Key Findings The consensus among experts and across best practice documents is that venousleg ulcers are best managed by a multidisciplinary team and with involvement of
the patient in the healing process. Comprehensive physical examinations and
detailed medical history taking are universally recommended. The literature
shows an agreement that the underlying cause(s) of the ulcer needs to be treated
parallel to the local wound itself in order to both facilitate healing and prevent
future recurrences.
At the level of local wound care, experts and guidelines almost universally
recommend debridement, infection control and compression as the three key,
crucial areas to be addressed by clinicians. Some disagreement exists as to the
efficacy of certain compression mechanism as compared to others.
Key
Conclusions
A wide variety of literature on evidence based best practice in the treatment and
prevention of venous leg ulcers is available.
There is a consensus on the need for a holistic approach addressing the overall
patient health as well as the local wound.
There exist broad guideline documents (e.g. 3.4.) as well as detailed, practice-
oriented recommendations (e.g. 3.2.).
Detailed documents, such as the RNAOs Nursing Best Practice Guideline, are
intended for bedside use by nursing practitioners and can be readily applied to
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venous leg ulcer patients.
The Ankle Brachial Pressure Index (ABPI) test is universally recommended as a
method of ruling out arterial disease and determining wound healability.
The importance of proper compression was a recurrent theme emerging from
reviewing the literature. High compression is generally recommended over low
compression, although other factors such as arterial disease and patientcompliance must also be factored in before making a choice.
Other
Interesting
Points
Best practice recommendations are derived from evidence sources of varying
degrees of quality. Some are confirmed by results from controlled, randomized
trials, while others have been reached as a consensus by a panel of wound care
experts and clinicians. The degree of evidence for recommendations cited below
is noted, where known.
The multi-disciplinary nature of venous leg ulcer care and the need for patient
compliance and education along the way of treating and preventing future
recurrences is underscored by most authors and panels.
One article extensively discussed the importance of proper nutrition as a
component of wound treatment and overall patient health.
3.1.A Transprofessional Comprehensive Assessment Model for Persons with Lower Extremity Legand Foot Ulcers,by Kevin Woo, Afsaneh Alavi, Mariam Botros, Laura Lee Kozosy, Marjorie
Fierheller, Kadhine Wiltshire and R. Gary Sibbald.
The study explores the impact of an interdisciplinary teams initial assessment for a person with
a lower extremity wound on the outcomes in those clients.
The study followed 111 clients over the course of four weeks while they were being cared for in
accordance with the CAWC/RNAO guidelines for the treatment of venous leg and diabetic foot
ulcers by an interprofessional team.
Key Findings:
o Many clients receiving home care services for wound care had not, prior to the study,
obtained the optimal assessment and treatment under the existing system.
o This in turn negatively impacted the clients healing times and resulted in spending in
excess of what would be sufficient under a comprehensive assessment model.
o The authors proposed and tested the interprofessional team and found the outcome to
be well-coordinated care delivered in a timely fashion.
o On the specific best practices in the treatment of leg ulcers, the authors cite studies
indicating that no specific dressing type applied in conjunction with compression on the
wound, is superior to others.
o As to the utility of compression, (i.e. pressure being applied to the wound through
hosiery, stockings, etc.) the authors join a number of other specialists cited in the study
who believe compression therapy to be crucialthe Recurrence rate of venous leg
ulcers was reduced from 75 to 25 per cent through the application of proper
compression.
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o Level B: evidence from well designed clinical studies but no randomized controlled
studies.
o Level C: evidence from expert committee reports and opinions and/or clinical
experience or respected authorities but without directly applicable studies of good
quality.
Out of the 65 recommendations 40 were supported by Level C evidence, 12 by Level B
evidence and 13 by Level A evidence.
For a summary of the 65 recommendations along with the level of evidence in their support, see
pages 10 to 17 of the RNAO document.
Among the recommendations, Recommendation #33 stands out as it states that absent other
complications, venous leg ulcers are best treated by a combination of compression (i.e.
graduated compression bandaging) and exercise. In terms of reliability, this recommendation is
supported by Level A evidence, i.e. the highest level of support of the kinds considered in the
guidelines development.
The subsequent 16 recommendations (#34 through #49) deal with specifics and details
regarding the level of compression which is suitable and the method(s) of its application as well
as long-term considerations for venous leg ulcer clients. These 16 recommendations are
supported by evidence of varying degrees of quality.
The document states that there is no evidence to support the use of high over moderate
pressure compression hoisery or vice versa in the prevention of ulcer recurrence, also noting
that compliance among patients with high pressure compression is lower. Studies considered in
the document suggest that clients should be prescribed the highest grade stockings they can
wear.
The theoretical amount of pressure produced by a bandage compression method is to be
calculated according to the formula P=4630xNxT/CxW where (La Places Law)o P=sub-bandage pressure (mmHg)
o N=number of layers
o T=tension within bandage (Kgforce)
o C=limb circumference (cm)
o W=width of bandage (cm)
Conclusions:
o The best practice guideline recommendations set is intended to improve outcomes for
venous leg ulcer clients by assisting practitioners and clients decisions regarding
appropriate care methods and options.o Adherence to the set of recommendations is believed to generally improve outcomes
and quality of care. However, the document stresses that the guidelines are not to be
applied irrespective of each cases particularities and specific factors The
recommendations made are not binding.
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are recommended in order to adequately assess the wounds healing prospects and risk
factors. The components of the history and physical examinations is recommended to
follow the RNAOs guideline document recommendations 1 through 7 and 14as well as
9 through 12. The level of evidence for this recommendation is C.
o Recommendation #3: determine the cause(s) of the chronic venous insufficiency based
on etiology: abnormal valves, obstruction, or calf muscle pump failure. This
recommendation, also supported by level C evidence.
o Recommendation #4: Implement appropriate compression therapy. As noted in the
reports synopsis, compression therapy is consensually deemed the gold standard for
venous leg ulcer care. The reports assessed level of evidence in support of this
recommendation is the highest possibleA. Pressure therapy is not suitable in cases
where arterial disease is also present. The report conforms to the RNAO assessment in
stating that high pressure compression should be the default choice, barring the
presence of complicating factors such as diabetes, arthritis, infection, and mild arterial
disease. The use of Intermittent Pneumatic Compression (IPC) is discussed and, based
on previously conducted trials, the authors agree that further evidence is necessary in
order to assess the effectiveness of IPC for venous leg ulcer treatment. The
recommended approach favours multi-layer compression over single-layer as well as
high compression over low compression. The authors underline the lack of evidence for
choosing among different types of high compression.
o Recommendation #5: Implement therapy for the complications resulting from chronic
venous insufficiency.
o Recommendation #6: Consider surgical management for certain cases.
o Recommendation #7: Communicate with patient and his/her family and establish
realistic healing expectations. The authors recognize the importance of good
communication and of addressing patient-centered concerns such as QoL, healing
prospects, long-term outlooks, etc.
o Recommendation #8: Assess the wound.
o Recommendation #9: Provide local wound caredebridement, bacterial balance,
moisture balance. This recommendation is strongly supported by evidence (level A).
The recommendation is to consider and select the appropriate method of debridement
and moisture regulation while taking into account the goal of treatment (e.g. healing or
maintenance) and other factors.
o Recommendation #10: incorporate specialists from other disciplines in order to ensure
proper addressing of other factors and co-factors in the wound healing/maintenance
process (e.g. mobility, nutrition, etc.)
Conclusions:
o The 2001 CAWC reports recommendations can be applied today. The RNAOs guideline
supplies evidence to support and update this list of recommendations.
o The report underscores the need of multidisciplinary teams in the planning for and
actual treatment of venous leg ulcers.
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o The report also includes a classification by key features of different compression
systems (Table 4) and different dressings (Table 6).
3.5.Compression for Preventing Recurrence of Venous Leg Ulcers (Review),by E Andrea Nelson,Sally EM Bell-Syer and Nicky A Cullum.
The reviews aim is to assess the effectiveness of compression therapy (bandages, stockings,
socks) in preventing the recurrence of pressure ulcers as well as to determine whether there is
an optimal level of pressure associated with the prevention of recurrence.
The review incorporates the results from two trials conducted in the UK and identified through a
19 database-wide search. The authors restricted the scope of their search to only include
randomized controlled trials evaluating compression bandages or hosiery.
The trials included were chosen based on their treatment of the following points: comparing
compression versus non-compression ; comparing different strengths of compression;
comparing different lengths of compression hosiery, compression bandages versus compressionhosiery, different types of compression hosiery and different types of compression regimens
(e.g. long/short stretch, single layer).
Key Findings:
o Of the two studies, one compared the use of moderate versus high pressure
compression hosiery (Harper 1996) and the other juxtaposed the effectiveness of two
types of moderate compression stockings in community clinics (Franks 1995).
o The authors found that in both studies, the not wearing of compression hosiery was
associated with high recurrence rates of ulcers, which constitutes indirect evidence for
the hypothesis that compression reduces recurrence.
o The review notes that, in the long run, there is no statistically significant difference inrecurrence rates between using high pressure or low pressure hosiery.
Conclusions:
o There is no evidence that compression prevents the recurrence of venous ulcers.
However, according to the authors review of the literature and analysis of the two UK
trials, this may represent a lack of evidence of a benefit rather than evidence for the
lack of benefitthe use of compression as a post-healing therapy is virtually universal,
which makes a controlled trial extremely hard to conduct; in addition, there exists
circumstantial evidence that clients who fail to follow the prescribed compression
regiment have higher recurrence rates than those who do follow it.o There is no evidence that high compression is more effective than moderate
compression in preventing venous ulcer recurrence. However, compliance is lower in
people who wear high level compression hosiery. It is the authors recommendation
that patients are prescribed the highest grade stockings they are able to wear.
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3.6.Summary Algorithm for Venous Ulcer Care with Annotations of Available Evidence,Association for Advancement of Wound Care (AAWC), 2005.
Prepared in the US, this guideline is the product of the work of an interdisciplinary task force
including physicians, PhDs, podiatrists, physical therapists, nurses and pharmacists.
The objective of the document is to establish a list of recommendations for achieving optimal
results in outcomes of treatment of venous ulcers.
The evidence used to support each recommendation was classified according to strength in one
of tree categories
o A: evidence including results from at least two randomized controlled trials in humans
o B: evidence of two or more historically controlled trials or convenience assignment or
convenience assignment or non-randomized controlled trials.
o C: evidence including one of the following: (1) results of one controlled trial; (2) results
of at least two case series or descriptive studies or a cohort study in humans; (3) expert
opinion.
The task force examined existing algorithms for care published prior to August 2002 and
evaluated the quality of evidence according to the scale above. Recommendations were arrived
on by way of expert consensus within the task force.
Key Findings: the recommendations emphasize the following steps in the care/treatment of
venous leg ulcers (level of evidence in support of each varies):
o A diagnosis consisting of taking a detailed patient history, a differential diagnosis
including taking an ankle-brachial index and a physical examination.
o Removing the cause or addressing the ulcer etiology by aiding venous return and
providing skin care.
o Applying compressionthe guidelines examine different compression options. Notably,
the evidence in support of this recommendation is overwhelmingly of level A, i.e. the
highest quality available.
o Local wound careincluding debridement, cleansing, managing moisture levels and
exudates (includes recommendation for maintaining a most wound environment for
healing enhancement and pain management).
o Considering other modalities in case of conservative therapy failing to work within 30
days.
Conclusions:
o Implementation of best practices and recommendations leads to decreased healing
times, increased healing rates and improves patients quality of life. The potential harmsinvolved depend on potential side effects of and adverse reactions to medications and
treatments.
o The outcomes considered for monitoring as indicators of successful venous ulcer care
are:
Ulcer healing rate and time
Ulcer recurrence
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Conclusions:
o The author recommends a holistic approach to the treatment and prevention of venous
leg ulcers, comprising of addressing the underlying condition (venous insufficiency),
nutritional deficiencies if present, proper local wound management (including moisture
balance and proper dressing choices) and appropriate compression.
4. DIABETIC FOOT ULCERSSynopsis:
# of Articles Reviewed 8
Types of
articles
Articles included in this section were selected from U.S. and Canadian
publications and represent a sample of the literature discussing best practices in
the treatment and prevention of foot ulcers in people with diabetes (PWD).
The majority of articles included are presentations of evidence-based practices
verified by literature or clinical experience. Some articles represent the authors
expert opinion.
Key Findings The review showed a consensus among experts that the chief cause of foot ulcers
in PWD is the combination of trauma and/or deformity and loss of protective
sensation in the extremities. Experts widely recommend the use of a
monofilament test to determine whether loss of such protective sensation in the
foot has occurred.
Consensus exists also regarding the key factors which promote foot ulcer healing,
namely a moist wound environment, debridement and infection control and
pressure offloading through specialized casts or shoes.
Different offloading methods are endorsed by different experts and reviews. Total
Contact Casts (TCCs) and Instant Total Contact Casts (ITCC) emerge as the best
methods of pressure offloading. Due to the care intensive nature of TCCs, somearticles recommend custom-designed footwear as an acceptable, viable
alternative.
Given the nature of diabetes and the complications arising from it, authors widely
agree that the approach to treating foot ulcers in PWD should be that of a
multidisciplinary team. Patient involvement and education is also crucial to the
successful and timely healing of ulcers and the prevention of future recurrences.
Experts are in agreement that ulcer classification is an important step in
predicting the course of healing and the choosing/adjusting of treatment
methods. The University of Texas Classification System emerges as the leading
classification tool endorsed by experts in the field.
Key
Conclusions
A holistic approach to treatment is crucial. A multidisciplinary clinical team must
address both the local wound and the underlying condition.
Pressure offloading is crucial to the healing process; TCCs are recommended, with
purpose-designed footwear being a good alternative.
Patient involvement and compliance, including dietary and lifestyle changes and
the establishing of realistic expectations and goals regarding the wound are an
important part of the treatment process.
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between 58 and 100 per cent after the implementation of a multidisciplinary team
approach to care.
Conclusions:
o The authors recommend strong preventive measures in order to reduce the incidence of
foot ulcers in PWD.
o The key components of a best practice treatment of diabetic foot ulcers are said to be
pressure offloading, maintaining of an appropriate moisture balance and avoidance of
infection.
o The authors emphasize strongly the need for patient involvement in the care process,
including possible life style changes (e.g. smoking cessation, diet changes) aimed at
improving health and reducing occurrence/recurrence risks.
4.2.Evaluation and Treatment of Diabetic Foot Ulcers,
by Ingrid Kruse and Steven Edelman.
This article presents an overview of major causes of foot ulcers in PWD, proper evaluation steps
to be taken and the key components of treatment to be applied.
Key Findings:
o In terms of evaluation, the authors recommend the assessment of neurological status,
vascular status of the patient and an examination of the wound itself.
o Neurological assessment is to be conducted in order to assess whether or not loss or
protective sensation in the lower extremities has set in. A recommended method is the
application of a 10-g monofilament to the foot in order to assess sensation.
o Vascular assessment is deemed by the authors to be essential for the evaluation and
healing of the diabetic foot ulcer.o In addition to the above, a complete wound assessment should take into account
wound location, size, shape, depth and border in order to, among other things, rule out
other possible causes for the foot ulceration.
o The authors recommendations for treating diabetic foot ulcers focus on three main
areas: debridement, offloading and infection control.
Debridement(i.e. removal of all non-viable tissue) should be performed to
decrease the risk of infection and facilitate the wound closing process by
reducing peri-wound pressure.
Offloadingis noted as the biggest challenge for clinicians dealing with diabetic
foot ulcers. Different methods are discussed (e.g. wedge shoes, Total ContactCasts or TCC and removable casts). The article points out that each have
advantages as well as drawbacks. For example, while removable casts allow for
daily wound inspection, patients do not comply with wearing them.
Infection Control - infections must be treated appropriately and in a timely
fashion.
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o Infection control and treatment (with antibiotics, surgical drainage or amputation
depending on the severity of the infection) are also identified as crucial points in the
treatment process.
o A team, multidisciplinary approach is recommended for the prevention of ulcers in
PWD. Regular foot examinations, therapeutic shoes and, in certain cases, surgical repair
of structural deformities are all said to be important components of an effective
preventive program.
Conclusions:
o The author advocates a multidisciplinary approach to diabetic foot ulcer treatment.
o The importance of debridement, pressure offloading and infection control are listed as
the three key areas of treatment focus.
o The article also makes recommendations as to the appropriate preventive measures to
be taken for preventing the occurrence or recurrence of diabetic foot ulcers in PWD.
4.4.Diabetic Foot Ulcers,by Kyle Goettl, Christine Pearson and Mariam Botros.This is a summary of a conference meeting of the World Union of Wound Healing Societies
including presentations from Australia, North America, Europe, the Middle East and Japan.
Key Findings:
o The authors note that the conference reinforced the importance of foot examination
and evaluation of neuropathies in the prevention and timely addressing of diabetic foot
ulcers. Factors such as loss of protective sensation, deformities and previous cases of an
ulcer or an amputation should all be taken into account for a complete and thorough
evaluation. The use of the monofilament test to assess sensation is endorsed.o The article discusses briefly the discrepancy between the best predictive scale for foot
ulcer classification (the University of Texas scale) and the most widely used (the Wagner
system). The SINBAD (Site, Ischemia, Neuropathy, Bacterial infection, Area and Depth)
scale is also noted to have shown recent favourable results in terms of accuracy in
predicting ulcer outcome.
o Offloading was mentioned as a key treatment pillar discussed by presenters at the
conference. The consensus was that the term offloading is restricted only to medical
devices applied for that purpose, while patients overall activity and lifestyle are also
important factors to be considered. It was emphasized that patients understanding of
their condition must be enhanced.
Conclusions: the following were presented to have been the main conclusions of the conference
o That a thorough and appropriate (i.e. conducted with the appropriate tool) evaluation
of the patient is crucial for both prevention and treatment of diabetic foot ulcers.
o That best practices must include infection prevention and treatment if necessary.
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treatment and making adjustments such as changing the type of dressing if
necessary.
Pressure offloading/redistribution is recommended as a component of the
wound treatment and also as a step toward preventing the recurrence of future
ulcers. Some evidence is presented for the effectiveness of total contact casting
(TCC). Ultimately attention is drawn to the importance of using some method of
pressure relief and educating the patient of the importance of this for their
wound healing.
o The report makes numerous references to the need for a multidisciplinary, team
approach to the treatment of diabetic foot ulcers.
o The guidelines also include the recommendation to evaluate and reassess the
treatments effectiveness on an ongoing basis and make the necessary adjustments as
need arises.
Conclusions:
o The guidelines document presents a comprehensive recommendations for the
assessment, prevention and management of diabetic foot ulcers.
o Recommendations on treatment focus on the areas of debridement, maintenance of an
appropriate moisture balance, monitoring and preventing infection and offloading
pressure.
o The document strongly advocates a teamwork, interdisciplinary approach for managing
foot ulcers in people with diabetes.
4.6.Diabetic Foot Ulcers,by Laura Bolton.The article is a report on the results of a study conducted to compare the effects of a
collagen/oxidized regenerated cellulose (C/ORC) dressing versus the saline-moistened gauze in
diabetic patients with foot ulcers.
The study proceeded with a sample of 138 patients being randomly assigned to either dressing
type following the taking of a baseline medical history. Dressings were changed as required for a
maximum period of 12 weeks. Healing efficacy, safety, and patient and physician preferences
were recorded.
Key Results:
o No significant differences in safety or efficacy were registered between the two dressing
types.o A higher rate of healing within 12 weeks was noted for the group using the C/ORC
dressing.
o Patients and physicians alike were found to prefer C/ORC dressings.
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o For the purposes of pressure offloading, the authors recommend TCCs or removable
casts.
o The focus of the treatment should be around debridement, infection control and
appropriate moisture balance maintenance.
4.8.A Transprofessional Comprehensive Assessment Model for Persons with Lower Extremity Legand Foot Ulcers,by Kevin Woo, Afsaneh Alavi, Mariam Botros, Laura Lee Kozosy, Marjorie
Fierheller, Kadhine Wiltshire and R. Gary Sibbald.
See 3.1. for a general overview of the article.
In a discussion of diabetic foot ulcers, the authors recommend that the four crucial components
for adequate healing are (1) adequate perfusion, (2) controlled infection or bacterial damage,
(3) pressure downloading and (4) sharp surgical debridement.
Notably, the authors recommend the use of sharp debridement over other methods for removal
of unviable tissue
5. OUTCOMES, OUTCOME MEASURES AND TOOLS IN WOUND CARESynopsis:
# of Articles Reviewed 5
Types of
articles
The articles included in this section focus on defining, and recommending
measures and outcomes to be used in monitoring and assessing wound healing.
Some articles discuss individual measures and factors while others discuss and
recommend holistic tools for overall wound outcome measurement and tracking
Key Findings The consensus among experts is that there exists a lack of a holistic,
comprehensive and easy to use tool for wound healing assessment for all chronic
wounds (including diabetic foot and venous leg ulcers).
Some tools which have been adapted and can be used for that purpose are the
PUSH (Pressure Ulcer Scale for Healing) which has been used to assess venous leg
ulcers and the Bates-Jensen Wound Assessment Tool which is adapted from the
Pressure Sore Status Tool and can be used reliably for all chronic wounds
according to one article.
The clinical outcomes most widely recommended as crucial to accurate wound
healing rate predictions as well as monitoring were wound surface area (length
and width) and wound depth.
Authors recommended that outcomes be patient-oriented and realistic (i.e.
setting realistic goals for the healing process and having the patients concerns
reflected in the goals and outcomes which are monitored).
Key
Conclusions
There exists a large degree of agreement as to the measures and outcomes
relevant for adequate assessment and tracking of the wound healing process (e.g.
wound dimensions, depth, exudates levels, etc.).
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There is a perceived lack of specially dedicated, holistic wound assessment tools
for chronic wounds such as diabetic foot ulcers and venous leg ulcers.
Goals and outcomes of treatment must be patient orientede.g. concerned not
only with the clinical side of the healing process but with the patients quality of
life and how it is impacted by the condition and the healing process.
OtherInteresting
Points
One article differentiated between outcome measures in three categories: (1)clinical efficacy measures; (2) health-related quality of life (HRQoL); and (3) health
economics.
The authors elaborate on scales and points of interest within each category,
noting that clinical outcomes should not be a stand-alone goal and thus should
not be the only thing measured along the course of care. By contrast, patient-
centered measures such as the value gain/loss to the patient from the condition
and its improvement is a critical outcome measure for determining the success of
a given intervention or type of treatment.
5.1.Outcomes Research Measuring Wound Outcomes,by Marco Romanelli, Valentina Dini,Maria Stefania Bertone and Ciniza Brilli.
The article is focused on wound outcome measures and evaluation criteria to be monitored for
wounds in general and for specific wound types.
The authors emphasize the importance of monitoring wound parameters as well as taking a
detailed medical history and a thorough physical examination.
Key Findings
o The authors point out that ongoing examination and monitoring of the wound is crucial.
o Parameters to monitor include length, width, depth, surface area, tissue viability,
duration, blood flow, oxygen, hardness, inflammation, pain and others.
o Specific to venous leg ulcers, the authors note the predominant practice is to trace thewounds outline on a transparent acetate sheet (in order to determine the wounds
perimeter) and to fill the wound with a hypoallergenic material to create a cast which is
then measured or use a cotton swab inside the wound (in order to determine the
wounds volume).
o According to Romanelli et al., most diagnoses are made on visual observation. The
authors assert that there is only one reliable, standardized visual wound assessment
tool content validated for all chronic wounds, namely the Bates-Jensen Wound
Assessment Tool, adapted from the valid, reliable Pressure Sore Status Tool.
o Determining the healability of an ulcer early on in the course of treatment as well as
tracking its healing course is stated to be greatly beneficial.o The authors cite studies which examine the wound perimeter (length and width) in
order to predict healing times with some accuracy. Together with measuring wound
depth, this is a key wound parameter to monitor and record, according to the article.
o For diabetic foot ulcers, the authors recommend the combined use of a monofilament
and vibration perception tests in order to estimate sensitivity in the patients
extremities. Also, transcutaneous oxygen tension measurement is said to be a well
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established technique for evaluating local ischemia in patients with diabetes, with
values lower than 40mmHg being an indicator of critical ischemia.
o For patients who have already developed ulcers, the authors recommend, as in the case
of venous leg ulcers, that the surface area and depth of the wound be closely monitored
and measured.
o Notably, the authors recommend that changes in patient-reported pain or sensation of
heat in the foot are important indicators to be accounted for as they may indicate a
potential bone involvement.
Conclusions:
o The authors believe that measuring wound surface area (length and width) is one of the
best and most important measurement indicators for tracking and predicting wound
healing for chronic wounds such as venous leg and diabetic foot ulcers.
o Along with that, the authors emphasize the importance of measuring wound depth and
taking a comprehensive medical history as being an important part of the best practices
toolkit to be applied in wound care.
5.2.What are Wound Care Outcomes?by Steven L. Soon and Suephy C. Chen.The article presents an overview of three types of wound care outcomes of relevance to
clinicians, patients and health care administrators.
The outcomes are organized in three categories: measures of clinical efficacy, health-related
quality of life and health economics. The authors discuss the appropriate measurements and
outcomes to take into consideration in each of the three categories.
Key Findings:o Clinical efficacy measuresthe authors list percentage of patients healed; mean time to
complete healing; percentage change in wound area; percentage change in wound area
debrided; exudates type and amount; infection reduction rate; predominant tissue type
at wound bed , etc.
o The authors point out that, while useful from a purely clinical and comparative
standpoint, such clinical efficacy outcomes may often represent outcomes which are not
important or not greatly important to the patient herself.
o Health-related quality of life measures (HRQoL)in contrast to clinical outcome
measures, these aim to determine the subjective experience of the disease for an
individual patient. These measures are grouped in four categories: (1) physical functioni.e. ones sense of physical energy and ability to carry out activities of daily living; (2)
psychological well being i.e. ones psychological response to ones health, including
depression, anxiety, fear, etc.;(3) social functioningi.e. ones ability to engage in
meaningful interpersonal relationships; and (4) somatic sensationi.e. ones disease-
related symptoms such as pain, etc.
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and responsive (i.e. the extent to which a given instrument is sensitive to important
changes in a patients condition over time).
5.3.Use of the PUSH Tool to Measure Venous Ulcer Healing,by Catherine R. Ratliff and George T.Rodeheaver.
The article reports the results of a study examining the viability of the Pressure Ulcer Scale for
Healing (PUSH) tool to assess healing in patients with venous leg ulcers.
The authors point out the critical importance of ongoing monitoring and assessments of wounds
over the course of treatment in order to determine progress.
The article states that no simple, easy to use, valid and reliable tool exists for the purpose of
monitoring the healing process for patient with venous leg ulcers.
Key Findings:
o The authors lay out the results of examining studies validating the use of the PUSH tool
in evaluating and monitoring pressure ulcer healing.o The article points out that the three key parameters used by the PUSH tool for pressure
ulcers are wound surface area, character of exudates and surface appearance of the
ulcer.
o It is noted that the literature suggests that these three outcomes/parameters may also
be important in monitoring venous leg ulcers.
o The authors descriptive study applied the PUSH tool to assess the healing of venous
ulcers in patients over the course of two months. The PUSH tool was administered and a
PUSH score was given to patients on the initial and then subsequent clinic visits in order
to monitor and track progress.
o After following twenty seven patients over two months, the study concluded thattwenty three had a decrease in their PUSH score by the end of the time period.
Furthermore, those who did not show a PUSH score improvement were found to have
been non-compliant with compression therapy.
Conclusions:
o The authors note that given the three components measured by PUSH (size, exudates,
tissue type), a lack of improvement in all categories should indicate that the course of
treatment should be changed.
o The use of the PUSH tool further allows for the comparison of treatment effectiveness
across clinics or across wound types, but cannot provide a measure of the effectivenessof any particular intervention.
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5.4.Analyzing Outcomes in Wound Care,by Glenda Motta.The author discusses the general features that outcome measurements and criteria must satisfy
in order to be useful and accurate. The article also cites some specific examples of measures to
be monitored for full thickness chronic wounds.
Key Findings:
o The authors stance is that outcomes should be patient-oriented and realistic (i.e. not
raising unrealistic expectations for wound healing for non-healable wounds for
example).
o The outcomes must be measurable and observable in concrete, objective terms.
o The article stresses the importance of patient involvement and endorsement of the
outcomes and the care plan. This, Motta argues, leads to an increased likelihood of
achieving the outcomes.
o The article recommends using the following outcomes, among others, as indicators of
wound healing in full-thickness wounds:
Reduction of erythema, edema or induration
Removal of necrotic debris
Surface area changes
Exudates is serious with no odour
Conclusions:
o The author recommends patient involvement and setting realistic goals for treatment
outcomes.
o The article also states that wound outcomes must be strictly measurable, patient-
oriented and monitored on an ongoing basis in order to ensure successful treatment
and make adjustments as necessary.
5.5.Improving Accuracy of Wound Measurement in Clinical Practice,by Madeline Flanagan.The article focuses on examining means for improving some commonly used, widespread
wound measurement techniques .
The article is based on a review of evaluative literature across databases from 1965 to 2003.
Key findings:
o Wound area measurement practicesthe article points out that common methods used
to measure wound surface area are imprecise. The author suggests that wound area is
most accurately measured by accurately determining the wound margins and thendetermining the surface area. A recommended method is using planimetry (e.g. with the
help of a portable digital planimetric device); diameter product measurements are said
to be the least reliable method of determining surface area followed by square counting
(i.e. imposing the traced wound outline on a graphed paper and counting the number of
pre-measured squares fitting into the outline).
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o Wound depth measurement practicesthe article points out that measuring wound
depth using a probe consistently underestimates the volume of larger, more irregularly
shaped wounds. The author stresses that measuring would depth and thus volume is
crucial to planning and setting realistic healing goals as full-thickness wounds generally
take longer to heal than partial-thickness wounds. No specific depth measurement
techniques were endorsed or suggested.
o The article points out that the appearance of the wound bed is an indicator of a healing
process, but is subjective and thus not consistently reliable as it relies on the
interpretation of a clinician which could vary.
o The author cites evidence that surface area reduction over time is an excellent indicator
of wound healing and, furthermore, provides a good basis for predicting healing
trajectories. This applies to both diabetic foot as well as venous leg ulcers.
Conclusions:
o Calculating wound surface area is a reliable and valid method of monitoring wound
healing.
o Moreover, the percentage change in wound area over the course of the first few weeks
of treatment is shown to be a helpful indicator for distinguishing healable from non-
healable ulcers, which in turn has profound implications for choosing the appropriate
course and type of treatment, etc. After reviewing the literature, the author concludes
that a surface area reduction of less than 20% to 40% over the initial 2 to 4 weeks is a
reliable indicator that the wound is not responding well to treatment.
o Lastly, the author points out the importance of consistent and regular monitoring and
measuring of the parameters, so that progress can be tracked and interventions
adjusted.
6. OTHER ARTICLESSynopsis:
# of Articles Reviewed 2
Types of
articles
The articles included in this section focused on salient points not directly related
to best practices for a specific wound type.
One article presents a discussion of the importance and status of best practice
implementation across Canada and the other is a discussion of a specific type of
therapy and its applications for the treatment of chronic wounds.
Key Findings Implementing best practices is seen to improve outcomes and thus as something
desirable to be encouraged.
The authors point out the difficulties in disseminating best practices (e.g. the
differing degrees to which clinicians are prepared or willing to implement those)
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6.1.Best Practice: Development, Implementation and Current Status Across Canada,by DouglasQueen, Tazim Virani, Pat Coutts, Heather L. Orsted. R. Gary Sibbald.
Following the issuing of best practice and evidence-based recommendations for wound care by
the Canadian Association of Wound Care (CAWC) in 2000, this article reviews the different
approaches to implementation of evidence-based practice across Canada along with the
benefits and problems associated with their implementation.
Key Points:
o Best practice defined as combining evidence, experience and opinion to improve client
care by reducing inappropriate variations in practice and by promoting the delivery of
high-quality, evidence-based health care.
o The authors take note of the fact that the shift toward best practice is difficult to
maintain, with relapse rates (i.e. clinicians reverting to previous methods, treatments
and practices) as high as 80 per cent.
o A list of criteria for best practice guidelines including being explicit, evidence-based,
logically thorough and avoiding recommending unproven approaches.
o Case Studies: the article reviews four approaches to best practice implementation
Facility-drivena company in Kitchener, Ontario champions best practices in
wound care through its services which are designed around advanced, evidence-
based wound care protocols.
Health Authority-driventhe Calgary Home care Skin and Wound Assessment
and Treatment Team (SWAT) is a multidisciplinary team facilitated by the
Calgary Home Care program with the aim to disseminate best practice
as well as the potential pitfalls of reverting to old practices over time.
Several distinct methods for spreading and encouraging best practice use are
outlined and briefly evaluateda facility/service provider approach, a health
authority-driven approach or a province-wide approach.
On the utility of the VAC therapy for treatment of chronic wounds, the findings
suggest that VAC therapy is and can be useful as an adjunctive therapy in thetreatment of chronic ulcers.
The article reviewed here acknowledges the need for further research into the
effects and benefits of VAC and urged that best practices such as taking a
complete medical history and performing a comprehensive medical examination
are crucial parts of the treatment process.
Key
Conclusions
Best practice implementation is encouraged by clinicians and experts alike.
The difficulties in best practice implementation and observance as well as the
different methods of best practice dissemination and encouragement are well
noted and documented.
The future of best practice implementation will depend upon the development of
electronic health records, the degree to which clinicians and health authorities
collaborate and the extent to which there is interest and work in the area of filling
gaps in the evidence and expanding on the existing best practice literature.
On VAC therapy, clinicians find it to be a useful adjunct therapy to supplement
the treatment of chronic wounds such as diabetic foot or venous leg ulcers.
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knowledge through education, clinical visits and procedure recommendations to
staff working for the Calgary Home Care program.
Provincially-drivenBest practices being encouraged and popularized by
professional associations such as the Registered Nurses Association of Ontario
(RNAO) using government funding. The RNAO developed and publicized a
comprehensive guideline for the assessment and management of venous leg
ulcers (reviewed below) by drawing on the expertise and opinion of a
multidisciplinary team including experts from private practice, long-term care
and acute care.
Nationally-driventhe CAWCs own efforts in promoting adherence to best
practices is noted and its role as an enabler underscored.
Conclusions:
o Implementing clinical practice guidelines can improve outcomes. However such
guidelines are often poorly implemented due to lack of information about the content
of such guidelines and their availability, the disbelief in the guidelines utility on the part
of practitioners among other reasons.
o The future of best practice implementation will strongly depend on (1) the proliferation
of electronic health records, (2) the progression of the trend for shared decision-making
between involved clinicians and (3) the increase/decrease in demand for information to
fill the gaps in research on best practices in specific wound care areas.
6.2.A Consensus Report on the Use of Vacuum-Assisted Closure in Chronic, Difficult-to-HealWounds,by R. Gary Sibbald, James Mahoney, The V.A.C. (R) Therapy Canadian ConsensusGroup.
This article presents the consensus opinion among wound care professionals on the use of
Vacuum Assisted Closure treatment.
The authors identify and acknowledge a need for further controlled studies to guide clinicians in
the integration of VAC therapy for chronic wound patients.
The article attempts to bridge that gap in available literature and controlled research by
synthesizing the opinions and recommendations of clinicians with experience in applying VAC
therapy.
The authors outline a general approach to be adhered to for patients with chronic wounds,
including an overall, comprehensive health assessment of the patient to determine anyunderlying physiological or pharmacological reasons for non-healing, before adjunctive
therapies (e.g.therapeutic ultrasound, surgery, VAC) are considered.
The Vacuum Assisted Therapy is an adjunctive therapy which works by introducing local
negative pressure in the wound area to promote healing. The system removes exudates and
helps maintain a moisture balance. The negative pressure further helps remove slough (i.e.
liquefied, non-viable tissue) from the wound bed.
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A consensus group, established in 2001 through a research grant by the VACs manufacturing
company, KCI Medical Canada Inc., was asked to provide opinions on 13 statements regarding
the use of VAC in patients with chronic wounds.
The majority of the groups members stated that they would use VAC therapy on chronic
wounds with delayed treatment. The panel considered intracutaneous fistulae, necrotic tissue,
undreated osteomyelitis and malignancy to be contraindications for the use of VAC therapy.
Experts were in general agreement that they would apply VAC immediately after wound
debridement, unless bleeding was a concern.
With different modes of pressure (low, high, constant, intermittent, etc.) available, panellists
recommended that continuous low-pressure be applied in cases where the VAC treatment is
associated with pain.
The panel recommended that any exposed tendons should be kept moist (e.g. through the use
of local moisture-retentive dressings) and that older patients in particular may not tolerate high
pressure well due to capillary fragility.
Conclusions:
o The panel made recommendations for the specific adoption of VAC therapy for chronic
wounds. Some modifications, such as not applying the VAC pressure immediately after
debridement in order to control bleeding and adjusting pressure to achieve optimal
tissue tension and fluid balance were recommended.
o The consensus group also recommended (and have since participated in) further clinical
controlled research into the use of VAC therapy for treating chronic wounds.
MMENDATION *LEVEL OF EVIDENCE