Management of patients with venous leg ulcers - Audit ... management of patients with venous leg...

Audit Protocol

The management ofpatients with venous leg ulcers

The management of patientswith venous leg ulcers

Audit Protocol

The management of patients with venous leg ulcers

Produced by the Dynamic Quality ImprovementProgramme, RCN Institute in conjunction with the Clinical Governance Research and DevelopmentUnit, Department of General Practice and PrimaryHealth Care, University of Leicester

We should like to thank the following whoundertook peer review of this protocol.

Steering group: Carol Dealey, Andrea Nelson,Edward Dickinson, Karen Jones, Lesley Duff

Advisory Panel: Richard Baker, Ian Seccombe,Mary Clay, Julia Schofield, Sir Norman Browse,Sara Twaddle

Users group: Dawne Squires, Sarah Pankhurst, Kath Robinson, and Kate Panico

Protocol developed by Xiao Hui Liao, Francine Cheater

The National Sentinel Audit Project for theManagement of Venous Leg Ulcers, from which thisaudit protocol was developed, was funded by theNHS Executive, Department of Health

Published by the Royal College of Nursing, 20 Cavendish Square, London W1M OAB

Management of patients with venous leg ulcersAudit protocol

Publication code 001 269

ISBN 1-873853-89-0

July 2000

PriceRCN members: £3.50RCN non-members: £4.50

Acknowledgements

The management of patients with venous leg ulcers Contents 1

1. Introduction 2Why an audit of patients with leg ulcers 2Background of national sentinel audit 2What is included in the protocol 2How to use this protocol 2Which patients are included 3Evidence grading 3

2. Summary of criteria 4The criteria - assessment 5The criteria - management 13The criteria - cleansing, dressing, contact sensitivity 15

3. Introducing change 19

References 20

Sources of further information 23

Appendix 1 -Documentation 24

Appendix 2 -Audit Form 24

Contents

The management of patients with venous leg ulcers Introduction

A. Why an audit of patients with leg ulcers?

Epidemiological data suggest that between 1.5-3.0per 1000 of the population have active leg ulcers(Fletcher et al 1997), and the prevalence increasesto 20 per 1000 in people over 80 years-of-age.

The total cost to the NHS of treating leg ulcers isestimated to be as high as £600 million a year(Douglas et al 1995).

A recent Effective Health Care Bulletin oncompression therapy for venous leg ulcersconcluded: “There is widespread variation inpractice, and evidence of unnecessary sufferingand costs due to inadequate management ofvenous leg ulcers in the community.” (NHS Centrefor Reviews and Dissemination, 1997)

Experience from initiatives set up to improvecommunity-based nursing management of legulcers (Moffat et al 1992; Thompson, 1993)highlighted the potential for more clinical andcost-effective practice through more widespreadadoption of evidence-based interventions.

B. Background for national sentinel audit for leg ulcers

The National Sentinel Audit Project for themanagement of venous leg ulcers was funded bythe NHS Executive for an 18-month period. The aimwas to pilot a methodology to improve the qualityof care for leg ulcer patients in terms of clinical andcost effectiveness. Evidence-based review criteriawere developed, based on the national guideline:‘Clinical practice guidelines for the management ofpatients with venous leg ulcers: recommendationsfor assessment, compression therapy, cleansing,debridement, dressings, contact sensitivity, training/education and quality assurance’ (RCN et al 1998).

Methods of data collection have been developeddrawing on the experience of practitioners,alongside the process of agreeing the evidence-based review criteria. Twenty pilot sites wererecruited to help the project team to test thedevelopment of the audit package andmethodology.

The projrct team is grateful to the participatingsites for their input and feedback in thedevelopment of the audit form.

The purpose of clinical audit is to improve thequality of care to patients locally. It is intended thatby providing nationally-produced guidelines and

audit tools, the RCN and its project partners will beable to help local teams improve the quality of careto patients. It is hoped that results will be collatednationally in an anonymised form to enablecomparative data analysis to take place. This willallow individual teams to benchmark theirperformance against others, and by establishingregional networks, to share good ideas and learnfrom the experiences of colleagues.

The initial project in which this audit protocol waspiloted was led by a collaborative partnership, co-ordinated by the RCN Dynamic QualityImprovement Programme, a steering group ofrepresentatives from other professionalorganisations, and an advisory group of experts inthe management of leg ulcers.

C. This protocol was originally developed for thenational sentinel audit management of leg ulcers. It contains:

◆ instructions to community nurses on how toconduct the audit

◆ detailed explanation and justification of thecriteria from research evidence

◆ criteria prioritised according to the strength ofthe research evidence and impact on theoutcome (Baker et al 1995)

◆ data collection form

◆ brief advice about change.

D. How to use this protocol

Planning the audit

A project leader must be identified who will takeresponsibility for involving clinical staff.Involvement in a clinical audit project is aboutdeveloping clinical practice, not just collectingdata. It is vital that the project leader seeks toenable clinical staff to improve the service. Furtherinformation on this can be found in theimplementation guide. If you are using this auditprotocol as a part of a regional or national project,comparing your results with others, you will needto audit all the criteria. If you are using thisprotocol locally you may choose only to use the‘must do’ criteria. You may wish to add criteriawhich refer to protocols for organising care locally.Ethical issues will also need to be considered at theplanning stage. It is important to ensure that localprocedures for ethical approval are followed.

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1. Introduction

The management of patients with venous leg ulcers Introduction 3

Data collection - one form per patient

You should use one data collection form for eachindividual patient. It is recommended that the datacollection will last for a three month period. Thecompleted form should be sent back to the projectleader in your organisation.

E. Which patients are included in the audit?

The protocol has been designed for communitynurses working in leg ulcer clinics as well as homecare-based practice. Leg ulcers are defined as areasof “loss of skin below the knee on the leg or footwhich take more than six weeks to heal” (EffectiveHealth Care Bulletin 1997). Patients diagnosed withvenous leg ulcers are included in the project. Thisincludes new patients, patients who are in theprocess of treatment and patients who have arecurrent ulcer. For more detailed criteria, pleaseread the Instruction for Audit Form in Appendix 2before you complete the form.

F. The evidence, on which the guidelinerecommendations from which the audit criteriawere developed, was graded as follows:

I Generally consistent findings in a majority ofmultiple acceptable studies.

II Either based on a single acceptable study, or aweak or inconsistent finding in multipleacceptable studies.

III Limited scientific evidence that does not meet allthe criteria of acceptable studies, or absence ofdirect studies of good quality. This includespublished or unpublished expert opinion(Waddell et al 1996).

Introduction

The management of patients with venous leg ulcers Summary4

2. Summary of Criteria

Assessment1. The records show that at the first assessment*, aclinical history (ulcer history, past medical history),physical examination (blood pressuremeasurement, weight, urinalysis) has beenundertaken.

2. The records show that on the first assessment,the ankle/brachial pressure index (ABPI) has beenmeasured.

3. The records show that the ulcer size and woundstatus (edge, base, position, surrounding skin) isdocumented at the first assessment.

4. The records show a referral via generalpractitioner to a specialist has been made in thefollowing situations: the ABPI is <0.8; the patientis diabetic; there is suspected malignancy; footinfection; healing has not started after 12 weeks ofcompression bandaging.

5. The records show that a bacterial swab has onlybeen taken when there is evidence of clinicalinfection for example, pyrexia, cellulitis, increasedpain and rapidly enlarging ulcer.

6. The records show that on the first assessment,the patient’s pain level has been assessed andwhere indicated, appropriate managementcommenced.

7. The records show that the measurement of ABPIhas been undertaken at least three monthly or inany of the following situations: sudden increase insize of ulcer; ulcer becomes painful; change incolour/temperature of foot/leg).

Management8. The records show that patient with venous legulcers and an ABPI ≥ 0.8 has received highcompression (multi-layer e.g. four-layer, three-layer or short stretch) bandaging.

9. The records show that the patient with a healedulcer has been educated about the need to wear,and how to correctly apply, compression stockings.

10. The records show that when wound cleansing isindicated, tap water or saline has been used forcleansing.

11. The records show that the patient has receivedsimple, low-cost, non-adherent wound dressingsunless more costly dressings are indicated (forexample, odour, and excessive exudate).

12. The records show that products containinglanolin or other potential allergens have not beenused on the patient.

13. The records show that topical antibiotics havenot been used on the patient.

* First assessment - a full assessment takes placewithin two weeks of first contact with the patient

The management of patients with venous leg ulcers Assessment 5

1. The records show that at the first assessment, aclinical history (ulcer history, past medical history),physical examination (blood pressure measurement,weight, urinalysis) has been undertaken.

Justification Lack of appropriate clinical assessment of patientswith limb ulceration in the community has oftenled to long periods of ineffective and ofteninappropriate treatment (Cornwall et al 1986; Roeet al 1993; Stevens et al 1997; Elliott et al 1996). Inaddition, inadequate diagnosis of ulcers of arterialorigin (Callam et al 1987a) leading to inadequatetreatment can have serious adverse consequencesfor the patient (for example, ischaemia). It isessential, therefore, that a patient presenting withleg ulcers has a thorough clinical history andphysical examination (Callam and Ruckley 1992).The clinical history and physical examination willassist the identification of both the underlyingcause of leg ulcers and any associated diseases, andwill influence decisions about prognosis, referral,investigation and management. If the practitioneris unable to conduct a physical examination, theymust refer the patient to an appropriately trainedprofessional.

Ulcer historyGuideline recommendations indicate thatinformation relating to ulcer history should include:the year of occurrence of the first ulcer; the site ofthe ulcers and of any previous ulcers; the number ofprevious episodes of ulceration; the time taken toheal in previous episodes; the time free of ulcers;past treatment methods; previous and current use ofcompression hosiery (RCN et al 1998).

The ulcer history will enable consideration ofclinical factors that may impact on treatment andhealing progress, as well as provide baselineinformation on ulcer history.

Medical historyTaking a medical history is an important part of theassessment to identify the type of ulcer. The personconducting the assessment must be aware that ulcersmay be arterial, diabetic, rheumatoid or malignantand should record any unusual appearance. This will assist the accurate identification of theaetiology of the ulcer, which has majorimplications for treatment choice (RCN et al 1998).

Although methods and populations makecomparison between studies difficult, there isgeneral consensus on the aetiological factors andthe medical criteria used to define venous, non-venous and mixed aetiology ulcers (AlexanderHouse Group 1992).

Arterial Ulcers - caused by an insufficient arterialblood supply to lower limb, resulting in ischaemiaand necrosis (Belcarno et al 1983; Carter 1973).

Rheumatoid ulcers - are commonly described asdeep, well-demarcated and punched-out inappearance. They are usually situated on thedorsum of the foot or calf (Lambert and McGuire1989) and are often slow to heal.

Diabetic ulcers - are usually found on the foot,often over a bony prominence such as the bunionarea, or under the metatarsal heads, and usuallyhave a sloughy or necrotic appearance (Cullum andRoe 1995). An ulcer in a diabetic patient may haveneuropathic, arterial and/or venous components(Browse et al 1988; Nelzen et al 1993). It isessential to identify the underlying aetiology.

Malignant ulcers - are a rare cause of ulcerationand exceptionally are a consequence of chroniculceration (Yang et al 1996; Baldursson et al 1995;Ackroyd and Young 1983).

Physical examinationA good examination of the legs and the ulcers isimportant to recognise the signs of chronic venousinsufficiency and arterial disease.

Venous diseaseThe ulcer is usually shallow (usually on the gaiterarea of leg) and may be associated with oedema,eczema, ankle flare, lipodermatosclerosis, varicoseveins, hyperpigmentation, atrophie blanche.

Arterial diseaseThe ulcer has a ‘punched out’ appearance, and thebase of wound is poorly perfused and pale. Othersymptoms may include: cold legs/feet; shiny, tautskin; dependent rubour; pale or blue feet;gangrenous toes.

2.1 Assessment of Patients with Leg Ulcers

The management of patients with venous leg ulcers Assessment

Mixed venous/arterialThe ulcers have features of venous ulcer incombination with signs of arterial impairment.

To assist in determining the type of ulcer thecriterion used for examining the appearance of theulcer is based on consensus statements, andliterature reviews that concur on well-knownfeatures of the different types of ulcers (Browse et al 1988; Alexander House Group 1992).

Other important elements of the assessment includetaking the patient’s blood pressure, weight and aurinalysis. Blood pressure is taken to screen forhypertension, and urinalysis is taken to screen forundiagnosed diabetes mellitus.

Although there is some empirical evidence ofinadequate assessment in practice, there are nostudies that examine patient outcomes thatcompare people who are given, or not given thebenefit of a full clinical history and physicalexamination. The recommendations for whatshould comprise a clinical history and physicalexaminations are therefore based on consensusopinion (RCN et al 1998).

Strength of evidence III

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2. The records show that on the first assessment, theankle/brachial pressure index (ABPI) has beenmeasured.

JustificationMeasurement of ABPI is to enable identification ofarterial disease for referral to specialist vascularclinics and to assess the appropriateness forcompression bandaging. All patients must be giventhe benefit of Doppler ultrasound measurement ofABPI by an appropriately trained professional. Thisprevents misdiagnosis that could result ininappropriate therapy, with possibly seriousadverse consequences for the patient.

Research suggests that diagnosis should not besolely based on the absence/presence of pedalpulses because there is generally poor agreementbetween manual palpation and ABPI (Brearley et al1992; Callam et al 1987b: Moffatt et al ,1994). Twolarge studies have shown that 67% and 37% oflimbs respectively with an ABPI of <0.9 hadpalpable foot pulses, with the consequent risk ofapplying compression to people with arterialdisease (Moffatt et al 1995; Callam et al 1987b).

The importance of making an objective assessmentof the ulcer by measuring ABPI is highlighted by anumber of studies (Nelzen et al 1994; Moffatt et al1994; Simon et al 1994).

Strength of evidence IAssessment ofPatients with Leg Ulcers

3. The records show that the ulcer size and woundstatus (edge, base, position, surrounding skin) isdocumented at the first assessment.

JustificationA detailed assessment and accurate written recordof ulcer characteristics should include the size, theedge, and the base, position of the ulcer and itssurrounding skin.

Serial measurement of size (length and width) ofthe ulcer is a reliable index of healing. Appropriatetechniques include tracing of the margins,measuring the two maximum perpendicular axes,or photography (Stacey 1991). The ulcer edge oftengives a good indication of progress and should becarefully documented (for example, shallow,epithelialising, punched out, rolling). The base ofthe ulcer should be described (for example,granulating, sloughy, and necrotic). The position ofthe ulcers should be clearly described (SIGN 1998).



4. The records show a referral via generalpractitioner to a specialist has been made in thefollowing situations: the ABPI is <0.8; the patient isdiabetic; there is suspected malignancy; footinfection; healing has not started after 12 weeks ofcompression bandaging.

JustificationAlthough no studies examining the outcomes ofpatients with leg ulcers referred from primary careor between health professionals within primarycare were found, the principal criteria forappropriate referral are widely agreed by experts.There is good evidence suggesting that patientsmay not be referred appropriately for specialistassessment. One study of district nurse recordsindicated that only 35% of leg ulcer patients werereferred at any stage for a specialist assessment,and only 7% had been examined by a vascularsurgeon (Lees and Lambert 1992). Nevertheless,most of the nurses in this study felt that furtherinvestigation of patients was necessary. Anotherstudy found that only six of 146 nurses would referpatients with rheumatoid or diabetic ulcers forspecialist advice (Roe et al 1993).

Urgent vascular referralAn urgent vascular referral should be made in thefollowing circumstances:

◆ the patient has an acutely infected or ischaemic foot

◆ there is an ischaemic complication fromcompression bandaging.

Urgent physician /dermatologist referralThe patient with severe cellulitis causing systemictoxicity should be referred to the on-callphysician/dermatologist.

Routine vascular referralThe patient should be referred to the vascularsurgeon if:

◆ venous ulcers treated for three months have notimproved

◆ ulcers fail to heal completely in one year

◆ patients with healed ulcers and a history ofvaricose veins with a view to surgery

◆ there is suspected malignancy.

Referral to dermatologistThe patient should be referred to the dermatologistif there is:

◆ a rash associated with the ulcer

◆ recurrent contact dermatitis

◆ unusual or atypical ulcers

◆ cellulitis, especially recurrent

◆ inflammatory reaction around the ulcer.

Referral to diabetologistThe patient should be referred to the diabetologistif there is:

◆ newly diagnosed diabetes

◆ unstable diabetes

◆ diabetic complications of the lower limbs

◆ neuropathy.


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5. The records show that a bacterial swab has onlybeen taken when there is evidence of clinicalinfection. For example, pyrexia, cellulitis, increasedpain and rapidly enlarging ulcer.

JustificationRoutine bacteriological swabbing is unnecessaryunless there is evidence of clinical infection suchas:

◆ inflammation/ redness/ evidence of cellulitis

◆ increased pain

◆ purulent exudate

◆ rapid deterioration of the ulcer

◆ pyrexia.

The influence of bacteria on ulcer healing has beenexamined in a number of studies (Trengove et al1996; Skene et al 1992; Ericksson et al 1984), andmost have found that ulcer healing is notinfluenced by the presence of bacteria.

Strength of evidence I

6. The records show that on the first assessment, thepatient’s pain level has been assessed and whereindicated, appropriate management commenced.

JustificationLeg ulcers are frequently painful. A significantproportion of patients with venous ulcers reportmoderate to severe pain (Dunn 1997; Hamer et al1994; Walshe 1995; Steven et al 1997; Cullum andRoe 1995; Hofman et al 1997). However, onesurvey found that 55% of district nurses did notroutinely assess pain in patients with leg ulcers(Roe et al 1993). Increased pain on mobility may beassociated with poorer healing rates (Johnson1995), and may also be a sign of some underlyingpathology such as arterial disease or infection(indicating that the patient may require referral forspecialised assessment).

Leg elevation is important since it can aid venousreturn and reduce pain and swelling in somepatients. However, leg elevation may make the painworse in others (Hofman et al 1997). Compressioncounteracts the harmful effects of venoushypertension and compression may relieve pain(Franks et al 1995).

Strength of the evidence II

Assessment of Patients with Leg Ulcers


7. The records show that the measurement of ABPIhas been undertaken at least three-monthly or inany of the following situations: sudden increase insize of ulcer; ulcer became painful; change incolour/temperature of foot/leg.

JustificationArterial disease may develop in patients withvenous disease (Sindrup et al 1987; Callam et al1987c; Scriven et al 1997) and significantreductions in ABPI can occur over relatively shortperiods (Nelzen et al 1994; Simon et al 1994;Scriven et al 1997). ABPI will also fall with age.

Strength of evidence II

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8. The records show that patients with venous legulcer and an ABPI ≥ 0.8 have received highcompression (multi-layer – that is four-layer, three-layer, or short stretch) bandaging.

JustificationCompression therapy is the most important elementof treatment of venous leg ulcers (Effective HealthCare Bulletin, 1997). Research has shown thatcompression improved healing rates compared totreatments using no compression (Rubin et al 1990;Eriksson et al 1984), and is also more cost-effectivebecause the faster healing rate saved nursing time(Taylor et al 1992 unpublished).

There is reliable evidence that high compression(25-35 mmHg - Thomas 1990) achieves betterhealing rates than low compression (Callam et al1992). Research has shown the benefits of multi-layer high compression system over single layer(Nelson et al 1995b; Travers et al 1992).

It is important to apply compression bandagescorrectly. Research has shown that incorrectlyapplied compression bandages may be harmful orineffective and may predispose the patient tocellulitis or skin breakdown. It has been shown thatmore experienced or well-trained bandagers obtainbetter and more consistent pressure results (Loganet al 1992; Nelson et al 1995a).

Strength of the evidence I

9. The records show that the patient with a healedulcer has been educated about the need to wear andhow to correctly apply compression stockings.

JustificationCompression hosiery is an important element in theprevention of recurrence of venous ulceration(Effective Health Care Bulletin, 1997). One trial hasshown that three to five year recurrence rates werelower in patients using strong support from classthree compression stockings (21%) than in thoserandomised to receive medium support from classtwo compression stockings (32%). Class twostockings, however, were better tolerated bypatients (Harper et al 1995).

Strength of the evidence II

2.2 Management of Patients with Venous Leg Ulcers

The management of patients with venous leg ulcers Cleansing, Debridement,Dressings, Contact Sensitivety


10. The records show that when wound cleansing isindicated, tap water or saline has been used forcleansing.

JustificationWounds and skin are colonised with bacteria thatdo not appear to impede healing. The purpose ofthe dressing technique is not to remove bacteriabut rather to avoid cross-infection with sources ofcontamination – for example, other sites of patientor other patients. A trial of clean versus aseptictechnique in the cleansing of tracheotomy woundsfailed to demonstrate any difference in infectionrates between the two methods (Sachine-Kardase etal 1992). There are no trials comparing aseptictechnique with clean technique in cleaning chronicwounds, including leg ulcers.

There is no evidence that the use of antisepticsconfers any benefit to preventing infection. In onestudy, cleansing traumatic wounds with tap waterwas associated with a lower rate of clinicalinfection when compared to sterile isotonic saline(Angeras et al 1992).

Strength of the evidence III

11. The records show that the patient has receivedsimple, low cost, non - adherent wound dressingsunless more costing dressing are indicated (forexample, odour, excessive exudate).

JustificationThere is strong evidence that the type of wounddressing has no effect on ulcer healing. A recentsystematic review (Nelson et al 1997) hasconcluded that hydrocolloid dressings confer nobenefit over simple, low-adherent dressings. Themost important aspect of treatment is theapplication of high compression bandaging. In theabsence of evidence, wound dressings should below cost, simple to reduce risk of contact sensitivityand low, or non-adherent, to avoid any damage tothe ulcer bed (RCN et al 1998).

Strength of evidence I

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2.3 Cleansing, Debridement, Dressings, Contact Sensitivity

The management of patients with venous leg ulcers Cleansing, Debridement,Dressings, Contact Sensitivety 13

12. The records show that products containinglanolin or other potential allergens have not beenused on the patient.

JustificationPatients with venous leg ulcers have variable ratesof sensitivity to products containing potentialallergens. Preparations commonly used as part ofthe leg ulcer treatment reported to cause contactsensitivity in certain individuals are listed below.Frequency of contact sensitivity and thecommonest allergens in leg ulcer patients havebeen examined in a number of studies (Blondeel etal 1978; Kulozik et al 1988; Cameron 1990;Cameron et al1991; Dooms-Goossens et al 1979;Frake et al 1979; Malten and Kuiper 1985;Paramsothy et al 1988).


Cleansing, Debridement, Dressings, Contact Sensitivity

Potential source

bath additives, creams, emollients, barriers and some baby products

elastic bandages and supports, elastic stockings, latex gloves worn by carer

bath oils, over the counter preparations such asmoisturisers and baby products

medicaments, creams and paste bandages

most creams, including corticosteriod creams,aqueous cream, emulsifying ointment and some

adhesive backed bandages and dressings

Type

Lanolin

Rubber

Perfume

Preservatives

Vehicle

Adhesive

Name of allergen

wool alcohol, amerchol 101

mercapto / carba/ thiuram mix

fragrance mix, Balsam of Peru

parabens (hydroxybenzoates)

cetyl alcohol, stearyl alcohol,cetylstearyl alcohol, paste bandages

resin colophony, ester of rosin

List of common allergens


13. The records show that topical antibiotics havenot been used on the patient.

JustificationColonisation of venous leg ulcers is the norm(Skene et al 1992) and there is no firm evidencethat it slows ulcer healing (Trengove et al 1996).The use of antibiotics therefore, should be kept to aminimum to discourage an increase in antibioticresistant bacteria. Topical antibiotics should not beapplied on patients with leg ulcers. The criterion issupported by consensus opinion (RCN et al 1998).


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2.3 Cleansing, Debridement, Dressings, Contact Sensitivity

Source

medicaments, tulle dressings, antibiotic creams and ointments

Topical antibiotics

Examples

neomycin, framycetin, bacitracin

List of topical antibodies

The management of patients with venous leg ulcers Intoducing Change 15

The primary health care team will need to makesure that all concerned have the opportunity tostudy the findings. A multi-disciplinary seminar or discussion meeting at a local level may beappropriate to discuss the findings. Identify thecriteria and standards of which you did less welland identify the possible reasons why. Your teamwill then need an agreed action plan to improve legulcer care. Consider the following suggestions:

◆ an educational and training programme fordistrict nurses and practice nurses and generalpractitioners

◆ a revised policy for the assessment andmanagement of patients with leg ulcers

◆ the introduction of a structured assessment form

◆ use of a computer record for patients with legulcers

◆ liaison with local tissue viability specialists,vascular surgeons, dermatologists,rheumatologists and diabetologists.

◆ keep any change as simple as possible toimplement.

The organisation - community NHS trust ◆ discuss the findings at manager level

◆ compare the results with the national average ofstandards. Identify strengths and weaknesses

◆ consider the following suggestions for strategiesfor implementation of the clinical guidelinerecommendations:

◆ providing resources (personnel, facilities, time,equipment etc) for regular training andeducation

◆ introducing new technologies (healthtechnology and information technology) intoprimary care

◆ developing a local structured assessment formfor leg ulcers.

◆ support from other agencies such as the RCN orlocal clinical audit office.

For more information see the ImplementationGuide in this series.

3. Introducing Change

The management of patients with venous leg ulcers References

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Gould DJ, Campbell S, Harding EF. Short stretchversus long stretch bandages in the treatment ofchronic venous ulcers. Unpublished.

Hamer C, Cullum NA, Roe BH 1994 Patients’perceptions of chronic leg ulcers. J of Wound Care;3(2):99-102.

Harper DR, Nelson EA, Gibson B et al 1995 Aprospective randomised trial of class 2 and class 3elastic compression in the prevention of venousulceration. Phlebology; suppl1:872-873.

Hofman D, Ryan TJ, Arnold F, Cherry GW,Lindholm C, Bjellerup M, Glynn C 1997 Pain invenous leg ulcers. J of Wound Care; 6(5):222-224.

Johnson M 1995 Patient characteristics andenvironmental factors in leg ulcer healing. J. Wound Care; 4(6):277-282.

Johnson M and Miller R 1996 Measuring healing inleg ulcers: practice considerations. Applied NursingResearch; 9(4):204-208.

Kralj B, Kosicek M Randomized comparative trialof single-layer and multi-layer bandages in thetreatment of venous leg ulcers. Unpublished.

Kulozik M, Powell SM, Cherry G, Ryan TJ 1988Contact sensitivity in community-based leg ulcerpatients. Clin Exp Dermatol; 13(2); 82-4.

Lambert E, McGuire J 1989 Rheumatoid leg ulcersare notoriously difficult to manage. How can onedistinguish them from gravitational and large vesselischaemic ulceration? What is the most effectivetreatment? Br J Rheumatol; 28 (5):421.

Lees TA and Lambert D 1992 Prevalence of lowerlimb ulceration in an urban health district. Br JSurg; 79:1032-1034.

Liskay AM, Mion LC, Davis BR 1993 Comparison oftwo devices for wound measurement. DermatologyNursing; 5(6):437-440.

Logan RA, Thomas S, Harding EF, Collyer GJ 1992A comparison on sub-bandage pressures producedby experienced and inexperienced bandagers. J ofWound Care; 1(3):23-26.

Majeske C 1992 Reliability of wound surface areameasurements. Physical Therapy; 72(2):138-41.

Malten KE, Kuiper JP 1985 Contact allergicreactions in 100 selected patients with ulcus cruris.Vasa; 14(4):340-5.

Moffatt CJ, Franks PJ, Oldroyd M, Bosanquet N,Brown P, Greenhalgh, McCollum CN 1992Community clinics for leg ulcers and impact onhealing. BMJ; 305(5):1389-1392.

Moffatt CJ, Oldroyd MI, Greenhalgh RM, Franks PJ1994 Palpating ankle pulses is insufficient indetecting arterial insufficiency in patients with legulceration. Phlebology; 9:170-172.

Moffatt CJ and O’Hare L 1995 Ankle pulses are notsufficient to detect impaired arterial circulation inpatients with leg ulcers. Journal of Wound Care;4(3):134-137.

Nelson EA, Ruckley CV, Barbenel JC 1995aImprovements in bandaging technique followingtraining. Journal of Wound Care; 4(4):181-184.

Nelson EA, Harper DE, Ruckley CV et al 1995b Arandomized trial of single layer and multi-layerbandages in the treatment of chronic venousulceration. Phlebology; suppl 1:915-916.

The management of patients with venous leg ulcers References 17

References

The management of patients with venous leg ulcers References

Nelson EA and Jones JE 1997 The development,implementation and evaluation of an educationalinitiative in leg ulcer management. Research andDevelopment Unit, Department of Nursing,University of Liverpool

Nelzen O, Bergqvist D, Lindhagen A 1993 High prevalenceof diabetes in chronic leg ulcer patients: a cross-sectionalpopulation study. Diabetic Medicine; 10:345-350.

Nelzen O, Bergqvist D, Lindhagen A 1994 Venousand non-venous leg ulcers: clinical history andappearance in a population study. Br Journal ofSurgery; 81:182-187.

Northeast A, Layer G, Wilson N et al 1990Increased compression expedites venous ulcerhealing. Presented at Royal Society of MedicineVenous Forum. London: RSM

Paramsothy Y, Collins M, Smith AG 1988 Contactdermatitis in patients with leg ulcers. Theprevalence of late positive reactions and evidenceagainst systemic ampliative allergy. ContactDermatitis; 18(1):30-6.

RCN Institute, Centre for Evidence Based Nursing,University of York, and the School of Nursing,Midwifery and Health Visiting, University ofManchester, 1998, Clinical practice guidelines for themanagement of patients with venous leg ulcers:recommendations for assessment, compression therapy,cleansing, debridement, dressings, contact sensitivity,training/education and quality assurance.

Roe BH, Luker KA, Cullum NA, Griffiths JM,Kenrick M 1993 Assessment, prevention andmonitoring of chronic leg ulcers in the community:report of a survey. J of Clin Nurs; 2:299-306.

Rubin J, Alexander J, Plecha E et al 1990 Unna’sboot vs polyurethane foam dressings for thetreatment of venous ulceration. A randomizedprospective study. Arch Surg; 125:489-90.

Sachine-Kardase A, Bardake Z, Basileiadou A,Dimpinoydes, Ouxoyne A, Patse O 1992 Study ofclean versus aseptic technique of tracheotomy carebased on the level of pulmonary infection.Noseleutike; 31(141):201-11.

Scottish Intercollegiate Guidelines Network: The careof patients with chronic leg ulcer. SIGN July 1998.

Scriven JM, Hartshorne T, Bell PRF, Naylor AR,London NJM. Single-visit venous ulcer assessmentclinic: the first year. Br J of Surg 1997; 84:334-336.

Simon DA, Freak L, Williams IM, McCollum CN 1994Progression of arterial disease in patients with healedvenous ulcers. J of Wound Care; 3(4):179-180.

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Skene AI, Smith JM, Dore CJ, Charlett A, Lewis JD1992 Venous leg ulcers: a prognostic index topredict time to healing. BMJ; 7:1191-1121.

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Stevens J, Franks PJ, Harrington MA 1997community/hospital leg ulcer service. J of WoundCare; 6(2):62-68.

Taylor P 1992 An examination of the problems andperceptions patients’ experience in complying withvenous leg ulcer management. UnpublishedBachelor of Nursing Dissertation, Swansea InstituteLibrary, Swansea.

Thomas S, Bandagers and Bandaging 1990 NursingStandards; Vol. 4; No. 39; pp46-47.

Thompson B A 1993 A management protocol forleg ulcers. Wound Management; 4: 81-84.

Travers J, Dalziel K, Makin G 1992 Assessment ofnew one-layer adhesive bandaging method inmaintaining prolonged limb compression and effectson venous ulcer healing. Phlebology; 7:59-63.

Trengove NJ, Stacey MC, McGechie DF, Mata S1996 Qualitative bacteriology and leg ulcerhealing. J of Wound Care; 5(6):277-280.

Waddell G, Feder G, McIntosh A, Lewis M,Hutchinson A 1996 Low Back Pain EvidenceReview. London: Royal College of GeneralPractitioners.

Walshe C 1995 Living with a venous ulcer: adescriptive study of patients’ experiences. Journalof Advanced Nursing; 22(6):92-100.

Yang D, Morrison BD, Vandongen YK, Singh A,Stacey MC 1996 Malignancy in chronic leg ulcers.Med J Aust; 164:718-721.

18

References

The management of patients with venous leg ulcers Sources 19

Useful contact addresses:

Tissue Viability Society

Glanville Centre

Salisbury district Hospital

Salisbury SP2 8BJ.

Tel: 01722 336262

http://www.tvs.org.uk/

The Audit Commission

1 Vincent Square

London SW1P 2PN

Tel: 020 7828 1212

http://www.audit-commission.gov.uk/

Scottish Intercollegiate Guidelines Network

The SIGN secretariat

Royal College of Physicians

9 Queen Street

Edinburgh EH2 1JQ

Tel: 0131 225 7324

http://www.show.scot.nhs.uk/sign/home.htm

The Cochrane Wounds Group

Department of Health Studies

University of York.

York Y01 5DD

Tel: 01904 43411

http://www.york.ac.uk/depts/hstd/centres/evidence/ev-intro.htm#cochrane-wounds-group

Clinical Governance Research and Development Unit

Department of General Practice and Primary HealthCare

University of Leicester

Leicester General Hospital

Leicester LE5 4PW

Tel: 0116 258 4873

http://www.le.ac.uk/cgrdu/index.html

NICE (National Institute for Clinical Excellence)

90 Long Acre

London, WC2E 9RZ

Tel: 020 7849 3444

http://www.nice.org.uk

Quality Improvement Programme Information Service

RCN

20 Cavendish Square

London W1M 0AB

Tel: 020 7647 3831

http://www.rcn.org.uk

Sources of Further Information

The management of patients with venous leg ulcers Appendix 1: Audit Form

Development of review criteriaBased on the national clinical guideline for legulcer management (RCN et al 1998), the reviewcriteria were developed according to a methoddeveloped by researchers in the ClinicalGovernance Research and Development Unit (Bakeret al 1995; Fraser et al 1997)

The method involved:

◆ identification of the key elements of care

◆ focused systematic reviews based on thenational clinical practice guideline (RCN et al1998) and justified by evidence

◆ taking into account consensus basedrecommendation considered to have animportant impact on outcome

◆ presentation of the criteria in a protocol.

The standardsA standard in this audit protocol refers to the levelof performance for each criterion, to whichcommunity nurses are aiming. The purpose ofcriteria and standards is to assist in theimprovement of care. The ultimate aim for most ofthe criteria is the achievement of a standard of100%, although it is recognised that there may beperfectly acceptable reasons for falling short of thislevel on some occasions in relation to some criteria.

20

Appendix 1. Documentation

The management of patients with venous leg ulcers Appendix 2: Audit Form 21

Appendix 2. Nursing Management of Venous Leg Ulcers inthe Community: Audit Form Please read the Instructions for audit form before you complete the form.

Date completed:

Ref. No. _______________ DOB ____________ Sex: M ❑ F ❑

First assessment by district nurse ❑ practice nurse ❑ specialist nurse ❑ other ______ grade ______

Patient mostly seen at home ❑ general clinic ❑ leg ulcer clinic ❑ other _________________

Patient mostly seen by district nurse ❑ practice nurse ❑ specialist nurse ❑ other ______ grade ______

Q 1. A clinical history and physical examination at assessment visit

Has the medical history been documented? yes ❑ no ❑

Has BP been recorded? yes ❑ no ❑

Has urinalysis been undertaken? yes ❑ no ❑

Has weight been recorded? yes ❑ no ❑

Did record show that patient had a previous ulcer history ? yes ❑ no ❑

If yes, have the following items been documented? duration of previous ulcer ❑ site ❑number ❑ method of treatment ❑ time to heal ❑ type ❑

First assessment visit: a full assessment takes place within two weeks of first contact of leg ulcer patient

Q 2. Doppler ABPI at first assessment visit yes ❑ no ❑

If not applicable, reason_____________________________________________________________

Level of ABPI L __________ R __________

Q 3. Has ulcer(s) size been measured at first assessment visit? yes ❑ no ❑ date measured__________

If yes, was this by: tape measure ❑ mapping ❑ photograph ❑ length and width ❑other ______________________________

Ulcer 1: length __cm width __cm duration of ulcer __mth is this a recurrent ulcer? yes ❑ no ❑Ulcer 2: length __cm width __cm duration of ulcer __mth is this a recurrent ulcer? yes ❑ no ❑Ulcer 3: length __cm width __cm duration of ulcer __mth is this a recurrent ulcer? yes ❑ no ❑

Q 4. Has pain assessment been undertaken? yes ❑ no ❑

Is the ulcer painful? yes ❑ no ❑

If yes, did patient receive analgesia? yes ❑ no ❑

Please complete the following items at the end of the audit period or if patient is lost to follow-up/isreferred/ulcer healed/patient died. Date of completion: __________________________________________

Q 5. Referral

Was referral made? yes ❑ no ❑ if yes, reasons: ____________________ date of referral_________

Referred to: specialist nurse ❑ GP ❑ vascular surgeon ❑ dermatologist ❑ diabetologist ❑other ______________________________

Q 6. Bacterial swab

Has a bacterial swab been taken? yes ❑ no ❑ was ulcer infected? yes ❑ no ❑

Please turn over page

The management of patients with venous leg ulcers Appendix 2: Audit Form22

Appendix 2. Nursing Management of Venous Leg Ulcers in theCommunity: Audit Form Q 7. Leg ulcer re-assessment

Has measurement of ulcer(s) size been repeated? yes ❑ no ❑

If yes, has ulcer size been repeated at every __________wk/wks

Q 8. Graduated compression yes ❑ no ❑ if not applicable, reasons ___________________________

If yes, type of bandage used Setopress ❑ Surepress ❑ Tensopress ❑ Comprilan ❑Robertson’s Ultra 4 ❑ Rosidal K ❑ 4 layer bandage ❑ Class 2/3 hosiery ❑other – list no more than five products __________________________________________________

Q 9. Which cleansing agent was used? tap water ❑ normal saline ❑ none rother – list no more than five products __________________________________________________

Q10. Which dressings were used? Hydrocolloid ❑ Foam ❑ Alginate ❑ Tulle gras ❑ NA Tricotex rother – please state __________________________________________________

Q11. Skin care

Have you used any skin care preparation? yes ❑ no ❑

If yes, was it: emollient ❑ steroid cream or ointment ❑ if other, please state________________

Q12. Outcome healed ❑ improved ❑ no change ❑ referral ❑ leg ulcer related admission ❑died ❑ other __________________________________________________

If ulcer(s) completely healed, please indicate the time to heal:Ulcer 1 __________wks Ulcer 2 ________wks Ulcer 3 ________wks

Q13. Prevention of recurrence

Did patient receive education on compression stockings? yes ❑ no ❑

If ulcer healed, did patient receive compression stockings? yes ❑ no ❑ not applicable ❑

If not applicable, please give reasons ____________________________________________________

Q14. Work load

On average, how many visits a week (leg ulcer care only)? _______________

Total number of visits (leg ulcer care only) ______

Average time for each visit <20 mins ❑ 20 mins ❑ 30 mins ❑ 40 mins ❑ >40 ❑(excluding travel time)

The management of patients with venous leg ulcers Appendix 2: Audit Form 23

Appendix 2. Instructions for Audit Form

Which patients are included in this audit?

Patients diagnosed with venous leg ulcers are included in the project. This includes new patients, patientswho are in the process of treatment and patients who have a recurrent ulcer. This retrospective audit willinclude patients with venous leg ulcers under your care at the present time. All patients who participate in theaudit project should have a sticker on their case records and an audit form attached.

Data collection - one form per patient

You should use one audit form for each individual patient. Questions 1 to 4 should be completed for patientswith venous leg ulcers at the start of the audit. Questions 5 to 14 should be completed at the end of the auditor if the patient is lost to follow-up/ is referred/ has a healed ulcer/ has died. Please state the date of completion.

General information The beginning of the form is general information about the patient. The reference number will be the patient’scase record number or any code number for identifying the patient locally.

Q 1. A clinical history and physical examination has been undertaken at the first assessment.

Previous ulcer history - if the patient has a leg ulcer history, the yes box should be ticked, and the follow-upquestions answered according to available information in the case notes at the time of the assessment visit.Medical history - the yes box should only be ticked when a full medical history is documented in the caserecords. The no box ticked if there is no medical history documented (if a patient does not have a history ofrelevant medical conditions for example, vascular disease, coronary heart disease etc, it must be documentedat the assessment visit). BP, urinalysis, weight - the yes box should only be ticked where those items wereundertaken and documented at the assessment visit.

Q 2. Doppler ABPI (ankle/brachial pressure index) has been measured at the first assessment visit.

Yes box is ticked when ABPI has been measured within two weeks of first contact. If yes, please state thedate of assessment and the level of ABPI. If a Doppler machine is not available in the team or practice or forany other reason the ABPI could not be undertaken, please tick the not applicable box and state the reason.

Q 3. Ulcers recorded at first assessment

The yes box should only be ticked when the ulcer size is documented at the first assessment visit. Pleaseindicate how you measure ulcer size normally. If you use any other method of measurement, please tick otherand state the method you have used. If the patient has more than one ulcer on both legs, please describe ulcertwo or add ulcer three if necessary. If more than three ulcers, please document the largest three sites.

Q 4. Pain assessment

The yes box should only be ticked where pain assessment has been undertaken on the patient at theassessment visit. For analgesia, the yes box should be ticked when the patient has received analgesia from anyprofessional. Form

Q 5. Referral

If the patient needs to be referred to a specialist, please give the date of referral, the main reason for referraland tick the type of specialist to which you have referred your patient. For most practices, the referral will goto the GP first. In this situation, please tick GP and also tick any other specialist to which you consider thepatient should be referred.

Q 6. Bacterial swab

If the yes box is ticked, please state the reasons.

The management of patients with venous leg ulcers Appendix 2: Audit Form24

Appendix 2. Instructions for Audit Form 2. Instructions for Audit

Q 7. Leg ulcer re-assessment

If yes box is ticked, please indicate how often the ulcer size has been re-measured.

Q 8. Graduated compression

Please indicate the products you have used on this patient (for the whole time of treatment) and tick more thanone type of bandage if necessary. For other, please do not list more than five products. If the patient was notsuitable for high compression (for example, acute heart failure, rheumatoid arthritis, grossly distended leg orany other reasons), please tick not applicable and state the reason.

Q 9. Cleansing agent

As you might use different agents for the patient during care, please tick the one you used most commonly -more than one if necessary. If you have used other cleansing agents, please list no more than five products.

Q10. Dressings

This applies to all dressings you have used for this patient during the whole treatment period. Please tick morethan one if necessary. If you tick other, please list up no more than five products you have used.

Q11. Skin care

If yes, please tick the preparation you have used - you can tick more than one box if it is necessary. If you tick other,please state no more than five products.

Q12. Outcome

Please indicate the outcome for this patient. If the ulcer healed, please indicate the time to heal the ulcer(s). Ifthe patient has more than one ulcer or ulcers on both legs, please describe the outcome of ulcer 2 or add ulcer3 if necessary.

Q13. Prevention of recurrence

For patients who have received education on compression stockings, the yes box should only be ticked if thishas been documented. If the ulcer is not healed by the end of the audit, or is not suitable for compressionstockings, please tick not applicable and state the reasons.

Q14. Work load

Number of visits a week - this will be the average number of visits per week in the period of care/or for most ofthe period of care. The average time for each visit will not include the first visit and will exclude travel time.

Where should you send the completed forms?

Once you have completed the form, please ensure all the items are filled in. The completed form should be sentback to the project leader in your organisation. Please make a photocopy of each form before sending it.

The management of patients with venous leg ulcers Notes 25

The management of patients with venous leg ulcers Notes26

© Copyright 2000: Royal College of Nursing. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, ortransmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise, without prior permission of the Publishers or alicence permitting restricted copying issued by the Copyright Licensing Agency, 90 Tottenham Court Road, London W1P 9HE. This publication may notbe lent, resold, hired out or otherwise disposed of by way of trade in any form of binding or cover other than that in which it is published, without theprior consent of the Publishers.

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