The management of patients with venous leg ulcers - Audit Protocol
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The management of patients with venous leg ulcers Audit Protocol
Acknowledgements Produced by the Dynamic Quality Improvement Programme, RCN Institute in conjunction with the Clinical Governance Research and Development Unit, Department of General Practice and Primary Health Care, University of Leicester We should like to thank the following who undertook 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 the Management of Venous Leg Ulcers, from which this audit protocol was developed, was funded by the NHS Executive, Department of Health Published by the Royal College of Nursing, 20 Cavendish Square, London W1M OAB Management of patients with venous leg ulcers Audit protocol Publication code 001 269 ISBN 1-873853-89-0 July 2000 Price RCN members: £3.50 RCN non-members: £4.50 The management of patients with venous leg ulcers
Contents 1. Introduction 2 Why an audit of patients with leg ulcers 2 Background of national sentinel audit 2 What is included in the protocol 2 How to use this protocol 2 Which patients are included 3 Evidence grading 3 2. Summary of criteria 4 The criteria - assessment 5 The criteria - management 13 The 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 The management of patients with venous leg ulcers Contents 1
1. Introduction A. Why an audit of patients with leg ulcers? audit tools, the RCN and its project partners will be able to help local teams improve the quality of care Epidemiological data suggest that between 1.5-3.0 to patients. It is hoped that results will be collated per 1000 of the population have active leg ulcers nationally in an anonymised form to enable (Fletcher et al 1997), and the prevalence increases comparative data analysis to take place. This will to 20 per 1000 in people over 80 years-of-age. allow individual teams to benchmark their The total cost to the NHS of treating leg ulcers is performance against others, and by establishing estimated to be as high as £600 million a year regional networks, to share good ideas and learn (Douglas et al 1995). from the experiences of colleagues. A recent Effective Health Care Bulletin on The initial project in which this audit protocol was compression therapy for venous leg ulcers piloted was led by a collaborative partnership, co- concluded: “There is widespread variation in ordinated by the RCN Dynamic Quality practice, and evidence of unnecessary suffering Improvement Programme, a steering group of and costs due to inadequate management of representatives from other professional venous leg ulcers in the community.” (NHS Centre organisations, and an advisory group of experts in for Reviews and Dissemination, 1997) the management of leg ulcers. Experience from initiatives set up to improve C. This protocol was originally developed for the community-based nursing management of leg national sentinel audit management of leg ulcers. ulcers (Moffat et al 1992; Thompson, 1993) It contains: highlighted the potential for more clinical and cost-effective practice through more widespread ◆ instructions to community nurses on how to adoption of evidence-based interventions. conduct the audit ◆ detailed explanation and justification of the B. Background for national sentinel audit for leg ulcers criteria from research evidence ◆ criteria prioritised according to the strength of The National Sentinel Audit Project for the the research evidence and impact on the management of venous leg ulcers was funded by outcome (Baker et al 1995) the NHS Executive for an 18-month period. The aim was to pilot a methodology to improve the quality ◆ data collection form of care for leg ulcer patients in terms of clinical and ◆ brief advice about change. cost effectiveness. Evidence-based review criteria were developed, based on the national guideline: D. How to use this protocol ‘Clinical practice guidelines for the management of patients with venous leg ulcers: recommendations Planning the audit for assessment, compression therapy, cleansing, A project leader must be identified who will take debridement, dressings, contact sensitivity, training/ responsibility for involving clinical staff. education and quality assurance’ (RCN et al 1998). Involvement in a clinical audit project is about Methods of data collection have been developed developing clinical practice, not just collecting drawing on the experience of practitioners, data. It is vital that the project leader seeks to alongside the process of agreeing the evidence- enable clinical staff to improve the service. Further based review criteria. Twenty pilot sites were information on this can be found in the recruited to help the project team to test the implementation guide. If you are using this audit development of the audit package and protocol as a part of a regional or national project, methodology. comparing your results with others, you will need to audit all the criteria. If you are using this The projrct team is grateful to the participating protocol locally you may choose only to use the sites for their input and feedback in the ‘must do’ criteria. You may wish to add criteria development of the audit form. which refer to protocols for organising care locally. The purpose of clinical audit is to improve the Ethical issues will also need to be considered at the quality of care to patients locally. It is intended that planning stage. It is important to ensure that local by providing nationally-produced guidelines and procedures for ethical approval are followed. 2 The management of patients with venous leg ulcers Introduction
Introduction Data collection - one form per patient You should use one data collection form for each individual patient. It is recommended that the data collection will last for a three month period. The completed form should be sent back to the project leader in your organisation. E. Which patients are included in the audit? The protocol has been designed for community nurses working in leg ulcer clinics as well as home care-based practice. Leg ulcers are defined as areas of “loss of skin below the knee on the leg or foot which take more than six weeks to heal” (Effective Health Care Bulletin 1997). Patients diagnosed with venous leg ulcers are included in the project. This includes new patients, patients who are in the process of treatment and patients who have a recurrent ulcer. For more detailed criteria, please read the Instruction for Audit Form in Appendix 2 before you complete the form. F. The evidence, on which the guideline recommendations from which the audit criteria were developed, was graded as follows: I Generally consistent findings in a majority of multiple acceptable studies. II Either based on a single acceptable study, or a weak or inconsistent finding in multiple acceptable studies. III Limited scientific evidence that does not meet all the criteria of acceptable studies, or absence of direct studies of good quality. This includes published or unpublished expert opinion (Waddell et al 1996). The management of patients with venous leg ulcers Introduction 3
2. Summary of Criteria Assessment 12. The records show that products containing lanolin or other potential allergens have not been 1. The records show that at the first assessment*, a used on the patient. clinical history (ulcer history, past medical history), physical examination (blood pressure 13. The records show that topical antibiotics have measurement, weight, urinalysis) has been not been used on the patient. undertaken. 2. The records show that on the first assessment, * First assessment - a full assessment takes place the ankle/brachial pressure index (ABPI) has been within two weeks of first contact with the patient measured. 3. The records show that the ulcer size and wound status (edge, base, position, surrounding skin) is documented at the first assessment. 4. The records show a referral via general practitioner to a specialist has been made in the following situations: the ABPI is
2.1 Assessment of Patients with Leg Ulcers 1. The records show that at the first assessment, a Although methods and populations make clinical history (ulcer history, past medical history), comparison between studies difficult, there is physical examination (blood pressure measurement, general consensus on the aetiological factors and weight, urinalysis) has been undertaken. the medical criteria used to define venous, non- venous and mixed aetiology ulcers (Alexander Justification House Group 1992). Lack of appropriate clinical assessment of patients Arterial Ulcers - caused by an insufficient arterial with limb ulceration in the community has often blood supply to lower limb, resulting in ischaemia led to long periods of ineffective and often and necrosis (Belcarno et al 1983; Carter 1973). inappropriate treatment (Cornwall et al 1986; Roe Rheumatoid ulcers - are commonly described as et al 1993; Stevens et al 1997; Elliott et al 1996). In deep, well-demarcated and punched-out in addition, inadequate diagnosis of ulcers of arterial appearance. They are usually situated on the origin (Callam et al 1987a) leading to inadequate dorsum of the foot or calf (Lambert and McGuire treatment can have serious adverse consequences 1989) and are often slow to heal. for the patient (for example, ischaemia). It is essential, therefore, that a patient presenting with Diabetic ulcers - are usually found on the foot, leg ulcers has a thorough clinical history and often over a bony prominence such as the bunion physical examination (Callam and Ruckley 1992). area, or under the metatarsal heads, and usually The clinical history and physical examination will have a sloughy or necrotic appearance (Cullum and assist the identification of both the underlying Roe 1995). An ulcer in a diabetic patient may have cause of leg ulcers and any associated diseases, and neuropathic, arterial and/or venous components will influence decisions about prognosis, referral, (Browse et al 1988; Nelzen et al 1993). It is investigation and management. If the practitioner essential to identify the underlying aetiology. is unable to conduct a physical examination, they Malignant ulcers - are a rare cause of ulceration must refer the patient to an appropriately trained and exceptionally are a consequence of chronic professional. ulceration (Yang et al 1996; Baldursson et al 1995; Ackroyd and Young 1983). Ulcer history Guideline recommendations indicate that Physical examination information relating to ulcer history should include: A good examination of the legs and the ulcers is the year of occurrence of the first ulcer; the site of important to recognise the signs of chronic venous the ulcers and of any previous ulcers; the number of insufficiency and arterial disease. previous episodes of ulceration; the time taken to heal in previous episodes; the time free of ulcers; past treatment methods; previous and current use of Venous disease compression hosiery (RCN et al 1998). The ulcer is usually shallow (usually on the gaiter area of leg) and may be associated with oedema, The ulcer history will enable consideration of eczema, ankle flare, lipodermatosclerosis, varicose clinical factors that may impact on treatment and veins, hyperpigmentation, atrophie blanche. healing progress, as well as provide baseline information on ulcer history. Arterial disease Medical history The ulcer has a ‘punched out’ appearance, and the base of wound is poorly perfused and pale. Other Taking a medical history is an important part of the symptoms may include: cold legs/feet; shiny, taut assessment to identify the type of ulcer. The person skin; dependent rubour; pale or blue feet; conducting the assessment must be aware that ulcers gangrenous toes. may be arterial, diabetic, rheumatoid or malignant and should record any unusual appearance. This will assist the accurate identification of the aetiology of the ulcer, which has major implications for treatment choice (RCN et al 1998). The management of patients with venous leg ulcers Assessment 5
2.1 Assessment of Patients with Leg Ulcers Mixed venous/arterial The ulcers have features of venous ulcer in combination with signs of arterial impairment. To assist in determining the type of ulcer the criterion used for examining the appearance of the ulcer is based on consensus statements, and literature reviews that concur on well-known features of the different types of ulcers (Browse et al 1988; Alexander House Group 1992). Other important elements of the assessment include taking the patient’s blood pressure, weight and a urinalysis. Blood pressure is taken to screen for hypertension, and urinalysis is taken to screen for undiagnosed diabetes mellitus. Although there is some empirical evidence of inadequate assessment in practice, there are no studies that examine patient outcomes that compare people who are given, or not given the benefit of a full clinical history and physical examination. The recommendations for what should comprise a clinical history and physical examinations are therefore based on consensus opinion (RCN et al 1998). Strength of evidence III 6 The management of patients with venous leg ulcers Assessment
2. The records show that on the first assessment, the 3. The records show that the ulcer size and wound ankle/brachial pressure index (ABPI) has been status (edge, base, position, surrounding skin) is measured. documented at the first assessment. Justification Justification Measurement of ABPI is to enable identification of A detailed assessment and accurate written record arterial disease for referral to specialist vascular of ulcer characteristics should include the size, the clinics and to assess the appropriateness for edge, and the base, position of the ulcer and its compression bandaging. All patients must be given surrounding skin. the benefit of Doppler ultrasound measurement of Serial measurement of size (length and width) of ABPI by an appropriately trained professional. This the ulcer is a reliable index of healing. Appropriate prevents misdiagnosis that could result in techniques include tracing of the margins, inappropriate therapy, with possibly serious measuring the two maximum perpendicular axes, adverse consequences for the patient. or photography (Stacey 1991). The ulcer edge often Research suggests that diagnosis should not be gives a good indication of progress and should be solely based on the absence/presence of pedal carefully documented (for example, shallow, pulses because there is generally poor agreement epithelialising, punched out, rolling). The base of between manual palpation and ABPI (Brearley et al the ulcer should be described (for example, 1992; Callam et al 1987b: Moffatt et al ,1994). Two granulating, sloughy, and necrotic). The position of large studies have shown that 67% and 37% of the ulcers should be clearly described (SIGN 1998). limbs respectively with an ABPI of
2.1 Assessment of Patients with Leg Ulcers 4. The records show a referral via general Routine vascular referral practitioner to a specialist has been made in the following situations: the ABPI is
Assessment of Patients with Leg Ulcers 5. The records show that a bacterial swab has only 6. The records show that on the first assessment, the been taken when there is evidence of clinical patient’s pain level has been assessed and where infection. For example, pyrexia, cellulitis, increased indicated, appropriate management commenced. pain and rapidly enlarging ulcer. Justification Justification Leg ulcers are frequently painful. A significant Routine bacteriological swabbing is unnecessary proportion of patients with venous ulcers report unless there is evidence of clinical infection such moderate to severe pain (Dunn 1997; Hamer et al as: 1994; Walshe 1995; Steven et al 1997; Cullum and ◆ inflammation/ redness/ evidence of cellulitis Roe 1995; Hofman et al 1997). However, one ◆ increased pain survey found that 55% of district nurses did not routinely assess pain in patients with leg ulcers ◆ purulent exudate (Roe et al 1993). Increased pain on mobility may be ◆ rapid deterioration of the ulcer associated with poorer healing rates (Johnson ◆ pyrexia. 1995), and may also be a sign of some underlying The influence of bacteria on ulcer healing has been pathology such as arterial disease or infection examined in a number of studies (Trengove et al (indicating that the patient may require referral for 1996; Skene et al 1992; Ericksson et al 1984), and specialised assessment). most have found that ulcer healing is not Leg elevation is important since it can aid venous influenced by the presence of bacteria. return and reduce pain and swelling in some patients. However, leg elevation may make the pain Strength of evidence I worse in others (Hofman et al 1997). Compression counteracts the harmful effects of venous hypertension and compression may relieve pain (Franks et al 1995). Strength of the evidence II The management of patients with venous leg ulcers Assessment 9
2.1 Assessment of Patients with Leg Ulcers 7. The records show that the measurement of ABPI has been undertaken at least three-monthly or in any of the following situations: sudden increase in size of ulcer; ulcer became painful; change in colour/temperature of foot/leg. Justification Arterial disease may develop in patients with venous disease (Sindrup et al 1987; Callam et al 1987c; Scriven et al 1997) and significant reductions in ABPI can occur over relatively short periods (Nelzen et al 1994; Simon et al 1994; Scriven et al 1997). ABPI will also fall with age. Strength of evidence II 10 The management of patients with venous leg ulcers Assessment
2.2 Management of Patients with Venous Leg Ulcers 8. The records show that patients with venous leg 9. The records show that the patient with a healed ulcer and an ABPI ≥ 0.8 have received high ulcer has been educated about the need to wear and compression (multi-layer – that is four-layer, three- how to correctly apply compression stockings. layer, or short stretch) bandaging. Justification Justification Compression hosiery is an important element in the Compression therapy is the most important element prevention of recurrence of venous ulceration of treatment of venous leg ulcers (Effective Health (Effective Health Care Bulletin, 1997). One trial has Care Bulletin, 1997). Research has shown that shown that three to five year recurrence rates were compression improved healing rates compared to lower in patients using strong support from class treatments using no compression (Rubin et al 1990; three compression stockings (21%) than in those Eriksson et al 1984), and is also more cost-effective randomised to receive medium support from class because the faster healing rate saved nursing time two compression stockings (32%). Class two (Taylor et al 1992 unpublished). stockings, however, were better tolerated by patients (Harper et al 1995). There is reliable evidence that high compression (25-35 mmHg - Thomas 1990) achieves better Strength of the evidence II healing rates than low compression (Callam et al 1992). 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 bandages correctly. Research has shown that incorrectly applied compression bandages may be harmful or ineffective and may predispose the patient to cellulitis or skin breakdown. It has been shown that more experienced or well-trained bandagers obtain better and more consistent pressure results (Logan et al 1992; Nelson et al 1995a). Strength of the evidence I The management of patients with venous leg ulcers Cleansing, Debridement,Dressings, Contact Sensitivety 11
2.3 Cleansing, Debridement, Dressings, Contact Sensitivity 10. The records show that when wound cleansing is 11. The records show that the patient has received indicated, tap water or saline has been used for simple, low cost, non - adherent wound dressings cleansing. unless more costing dressing are indicated (for example, odour, excessive exudate). Justification Wounds and skin are colonised with bacteria that Justification do not appear to impede healing. The purpose of There is strong evidence that the type of wound the dressing technique is not to remove bacteria dressing has no effect on ulcer healing. A recent but rather to avoid cross-infection with sources of systematic review (Nelson et al 1997) has contamination – for example, other sites of patient concluded that hydrocolloid dressings confer no or other patients. A trial of clean versus aseptic benefit over simple, low-adherent dressings. The technique in the cleansing of tracheotomy wounds most important aspect of treatment is the failed to demonstrate any difference in infection application of high compression bandaging. In the rates between the two methods (Sachine-Kardase et absence of evidence, wound dressings should be al 1992). There are no trials comparing aseptic low cost, simple to reduce risk of contact sensitivity technique with clean technique in cleaning chronic and low, or non-adherent, to avoid any damage to wounds, including leg ulcers. the ulcer bed (RCN et al 1998). There is no evidence that the use of antiseptics Strength of evidence I confers any benefit to preventing infection. In one study, cleansing traumatic wounds with tap water was associated with a lower rate of clinical infection when compared to sterile isotonic saline (Angeras et al 1992). Strength of the evidence III 12 The management of patients with venous leg ulcers Cleansing, Debridement,Dressings, Contact Sensitivety
Cleansing, Debridement, Dressings, Contact Sensitivity 12. The records show that products containing lanolin or other potential allergens have not been used on the patient. Justification Patients with venous leg ulcers have variable rates of sensitivity to products containing potential allergens. Preparations commonly used as part of the leg ulcer treatment reported to cause contact sensitivity in certain individuals are listed below. Frequency of contact sensitivity and the commonest allergens in leg ulcer patients have been examined in a number of studies (Blondeel et al 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). Strength of evidence III List of common allergens Type Name of allergen Potential source Lanolin wool alcohol, amerchol 101 bath additives, creams, emollients, barriers and some baby products Rubber mercapto / carba/ thiuram mix elastic bandages and supports, elastic stockings, latex gloves worn by carer Perfume fragrance mix, Balsam of Peru bath oils, over the counter preparations such as moisturisers and baby products Preservatives parabens (hydroxybenzoates) medicaments, creams and paste bandages Vehicle cetyl alcohol, stearyl alcohol, most creams, including corticosteriod creams, cetylstearyl alcohol, paste bandages aqueous cream, emulsifying ointment and some Adhesive resin colophony, ester of rosin adhesive backed bandages and dressings The management of patients with venous leg ulcers Cleansing, Debridement,Dressings, Contact Sensitivety 13
2.3 Cleansing, Debridement, Dressings, Contact Sensitivity 13. The records show that topical antibiotics have not been used on the patient. Justification Colonisation of venous leg ulcers is the norm (Skene et al 1992) and there is no firm evidence that it slows ulcer healing (Trengove et al 1996). The use of antibiotics therefore, should be kept to a minimum to discourage an increase in antibiotic resistant bacteria. Topical antibiotics should not be applied on patients with leg ulcers. The criterion is supported by consensus opinion (RCN et al 1998). Strength of evidence III List of topical antibodies Examples Source Topical antibiotics neomycin, framycetin, bacitracin medicaments, tulle dressings, antibiotic creams and ointments 14 The management of patients with venous leg ulcers Cleansing, Debridement,Dressings, Contact Sensitivety
3. Introducing Change The primary health care team will need to make sure that all concerned have the opportunity to study the findings. A multi-disciplinary seminar or discussion meeting at a local level may be appropriate to discuss the findings. Identify the criteria and standards of which you did less well and identify the possible reasons why. Your team will then need an agreed action plan to improve leg ulcer care. Consider the following suggestions: ◆ an educational and training programme for district nurses and practice nurses and general practitioners ◆ a revised policy for the assessment and management of patients with leg ulcers ◆ the introduction of a structured assessment form ◆ use of a computer record for patients with leg ulcers ◆ liaison with local tissue viability specialists, vascular surgeons, dermatologists, rheumatologists and diabetologists. ◆ keep any change as simple as possible to implement. The organisation - community NHS trust ◆ discuss the findings at manager level ◆ compare the results with the national average of standards. Identify strengths and weaknesses ◆ consider the following suggestions for strategies for implementation of the clinical guideline recommendations: ◆ providing resources (personnel, facilities, time, equipment etc) for regular training and education ◆ introducing new technologies (health technology and information technology) into primary care ◆ developing a local structured assessment form for leg ulcers. ◆ support from other agencies such as the RCN or local clinical audit office. For more information see the Implementation Guide in this series. The management of patients with venous leg ulcers Intoducing Change 15
References Ackroyd JS, Young AE 1983 Leg ulcers that do not Callam MJ, Harper DR, Dale JJ et al 1987b Arterial heal. BMJ; 286 (6360):207-8. disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley Ahroni JH, Boyko EJ, Pecoraro RE 1992 Reliability leg ulcer study. BMJ; 294 (6577):929-31. of computerised wound surface area determinations. Wounds: a compendium of clinical Callam MJ, Ruckley C, Dale JJ et al 1987c Hazards research and practice; 4(4):133-7. of compression treatment of the leg: an estimate from Scottish surgeons. BMJ; 295:1382. Alexander House Group. Consensus paper on venous leg ulcers 1992 Phlebology; 7:48-58. Cameron J 1990 Patch testing for leg ulcer patients. Nursing Times (Wound Care Suppl); 86(25):63-75. Angeras HM, Brandberg A, Falk A, Seeman T 1992 Comparison between sterile saline and tap water Cameron J, Wilson C, Powerll S, Cherry GW, Tyan T for the cleansing of acute soft tissue wounds. 1991 An update on contact dermatitis in leg ulcer European Journal of Surgery;158:347-50. patients. Symposium on Advanced Wound Care. San Francisco 7,8,9, 26. Baker R, Fraser RC 1995 Development of review criteria: linking guidelines and assessment of Carter SA 1973 The relationship of distal systolic quality. BMJ; 311: 370-3. pressures to healing of skin lesions in limbs with arterial occlusive disease, with special reference to Baldursson B, Sigureirsson B and Lindelof B 1995 diabetes mellitus. Scand J Clin Lab Invest; 31:239 Venous leg ulcers and squamous cell carcinoma: a (suppl 128). large scale epidemiological study. Br J Dermatology; 133:571-574. Cornwall JV, Dore CJ, Lewis JD 1986 Leg ulcers: epidemiology and aetiology. Br J Surg; 73 Belcaro G et al 1983 Arterial pressure measurements (9):693-6. correlated to symptoms and signs or peripheral arterial disease. Acta Chir Belg; 83 (5):320-6. Corson JD, Jacobs RL, Karmody AM, Leather RP, Shah DM 1986 The diabetic foot. Curr Probl Surg; Blondeel A, Oleffe J, Achten G 1978 Contact allergy 10:725-88. in 330 dermatological patients. Contact Dermatitis; 4(5):270-6. Cullum N, Fletcher A, Semylen A, Sheldon TA 1997 Compression therapy for venous leg ulcers. Quality Brearley SM, Simms MH, Shearman CP 1992 in Health Care; 6:226-231. Peripheral pulse palpation: an unreliable physical sign. Annals of the Royal College of Surgeons of Cullum N and Roe B 1995 Leg ulcers nursing England; 74:169-171. management - a research-based guide. Bailliere Tindall: London. Browse NL, Burns KG, Lea Thomas M 1988 Diseases of the veins: Pathology, Diagnosis and Dooms-Goossens A, Degreef H, Parijs M, Maertens treatment. Edward Arnold. London. M 1979 A retrospective study of patch test results from 163 patients with stasis dermatitis or leg Buntinx F, Becker H, Briers MD, De Keyser G, Flour ulcers. II. Retesting of 50 patients. Dermatology; M, Nissen G, Raskin T, De Vet H 1996 Inter- 159(3):231-8. observer variation in the assessment of skin ulceration. J of Wound Care; 5(4):166-169. Douglas WS, Simpson NB 1995 Guidelines for the management of chronic venous leg ulceration. Callam MJ 1992 Prevalence of chronic leg Report of a multidisciplinary workshop. British ulceration and severe chronic disease in Western Journal of Dermatology; 132: 446-452. Countries. Phlebology Supplement; 1:6-12. Dunn C, Beegan A, Morris S 1997 Towards Callam M, Harper D R, Dale JJ et al 1992Lothian evidence based practice. Focus on Venous ulcers Forth Valley leg ulcer healing trial - part 1: elastic Mid term Review Progress Report compiled for versus non-elastic bandaging in the treatment of Kings Fund PACE project. London Kings Fund. chronic leg ulceration. Phlebology; 7:136-41. Callam MJ, Harper DR, Dale JJ et al 1987a Chronic ulcer of the leg: clinical history, BMJ; 294 (6584):1389-91. 16 The management of patients with venous leg ulcers References
References Effective Health Care Bulletin. Compression Kralj B, Kosicek M Randomized comparative trial therapy for venous leg ulcers 1997 NHS Centre for of single-layer and multi-layer bandages in the Reviews and Dissemination, University of York, treatment of venous leg ulcers. Unpublished. August; 3(4). Kulozik M, Powell SM, Cherry G, Ryan TJ 1988 Elliott E, Russell B, Jaffrey G 1996 Setting a Contact sensitivity in community-based leg ulcer standard for leg ulcer assessment. J of Wound Care; patients. Clin Exp Dermatol; 13(2); 82-4. 5(4):173-175. Lambert E, McGuire J 1989 Rheumatoid leg ulcers Eriksson G, Eklund A, Liden S et al 1984 are notoriously difficult to manage. How can one Comparison of different treatments of venous leg distinguish them from gravitational and large vessel ulcers: a controlled study using ischaemic ulceration? What is the most effective stereophotogrammetry. Curr Ther Res; 35:678-84. treatment? Br J Rheumatol; 28 (5):421. Etris MB, Pribble J, LaBrecque J 1994 Evaluation of Lees TA and Lambert D 1992 Prevalence of lower two wound measurement methods in a multi- limb ulceration in an urban health district. Br J center, controlled study. Ostomy Wound Surg; 79:1032-1034. Management; 40(7):44-48. Liskay AM, Mion LC, Davis BR 1993 Comparison of Fletcher A, Cullum N, Sheldon TA 1997 A two devices for wound measurement. Dermatology systematic review of compression therapy for Nursing; 5(6):437-440. venous leg ulcers. BMJ; 315:576-579. Logan RA, Thomas S, Harding EF, Collyer GJ 1992 Frake JE, Peltonen L, Hopsu-Havu VK 1979 Allergy A comparison on sub-bandage pressures produced to various components of topical preparations in by experienced and inexperienced bandagers. J of stasis dermatitis and leg ulcer. Contact Dermatitis; Wound Care; 1(3):23-26. 5(2):97-100. Majeske C 1992 Reliability of wound surface area Franks PJ, Oldroyd MI, Dickson D et al 1995 Risk measurements. Physical Therapy; 72(2):138-41. factors for leg ulcer recurrence: a randomized trial Malten KE, Kuiper JP 1985 Contact allergic of two types of compression stocking. Age and reactions in 100 selected patients with ulcus cruris. Ageing; 24:4490-4494. Vasa; 14(4):340-5. Gould DJ, Campbell S, Harding EF. Short stretch Moffatt CJ, Franks PJ, Oldroyd M, Bosanquet N, versus long stretch bandages in the treatment of Brown P, Greenhalgh, McCollum CN 1992 chronic venous ulcers. Unpublished. Community clinics for leg ulcers and impact on Hamer C, Cullum NA, Roe BH 1994 Patients’ healing. BMJ; 305(5):1389-1392. perceptions of chronic leg ulcers. J of Wound Care; Moffatt CJ, Oldroyd MI, Greenhalgh RM, Franks PJ 3(2):99-102. 1994 Palpating ankle pulses is insufficient in Harper DR, Nelson EA, Gibson B et al 1995 A detecting arterial insufficiency in patients with leg prospective randomised trial of class 2 and class 3 ulceration. Phlebology; 9:170-172. elastic compression in the prevention of venous Moffatt CJ and O’Hare L 1995 Ankle pulses are not ulceration. Phlebology; suppl1:872-873. sufficient to detect impaired arterial circulation in Hofman D, Ryan TJ, Arnold F, Cherry GW, patients with leg ulcers. Journal of Wound Care; Lindholm C, Bjellerup M, Glynn C 1997 Pain in 4(3):134-137. venous leg ulcers. J of Wound Care; 6(5):222-224. Nelson EA, Ruckley CV, Barbenel JC 1995a Johnson M 1995 Patient characteristics and Improvements in bandaging technique following environmental factors in leg ulcer healing. training. Journal of Wound Care; 4(4):181-184. J. Wound Care; 4(6):277-282. Nelson EA, Harper DE, Ruckley CV et al 1995b A Johnson M and Miller R 1996 Measuring healing in randomized trial of single layer and multi-layer leg ulcers: practice considerations. Applied Nursing bandages in the treatment of chronic venous Research; 9(4):204-208. ulceration. Phlebology; suppl 1:915-916. The management of patients with venous leg ulcers References 17
References Nelson EA and Jones JE 1997 The development, Simon DA, Freak L, Williams IM, McCollum CN 1994 implementation and evaluation of an educational Progression of arterial disease in patients with healed initiative in leg ulcer management. Research and venous ulcers. J of Wound Care; 3(4):179-180. Development Unit, Department of Nursing, Sindrup JH, Groth S, Avnstorp C, Tonnesen KH, University of Liverpool Kristensen JK 1987 Coexistence of obstructive Nelzen O, Bergqvist D, Lindhagen A 1993 High prevalence arterial disease and chronic venous stasis in leg of diabetes in chronic leg ulcer patients: a cross-sectional ulcer patients. Clin Exp Dermatol; 12(6):160-3. population study. Diabetic Medicine; 10:345-350. Skene AI, Smith JM, Dore CJ, Charlett A, Lewis JD Nelzen O, Bergqvist D, Lindhagen A 1994 Venous 1992 Venous leg ulcers: a prognostic index to and non-venous leg ulcers: clinical history and predict time to healing. BMJ; 7:1191-1121. appearance in a population study. Br Journal of Stacey MC, Burnadnd KG, Layer GT, Pattison M, Surgery; 81:182-187. Browse NL 1991 Measurement of the healing of Northeast A, Layer G, Wilson N et al 1990 venous ulcers. Aust N Z J Surg; 61:844-8. Increased compression expedites venous ulcer Stevens J, Franks PJ, Harrington MA 1997 healing. Presented at Royal Society of Medicine community/hospital leg ulcer service. J of Wound Venous Forum. London: RSM Care; 6(2):62-68. Paramsothy Y, Collins M, Smith AG 1988 Contact Taylor P 1992 An examination of the problems and dermatitis in patients with leg ulcers. The perceptions patients’ experience in complying with prevalence of late positive reactions and evidence venous leg ulcer management. Unpublished against systemic ampliative allergy. Contact Bachelor of Nursing Dissertation, Swansea Institute Dermatitis; 18(1):30-6. Library, Swansea. RCN Institute, Centre for Evidence Based Nursing, Thomas S, Bandagers and Bandaging 1990 Nursing University of York, and the School of Nursing, Standards; Vol. 4; No. 39; pp46-47. Midwifery and Health Visiting, University of Manchester, 1998, Clinical practice guidelines for the Thompson B A 1993 A management protocol for management of patients with venous leg ulcers: leg ulcers. Wound Management; 4: 81-84. recommendations for assessment, compression therapy, Travers J, Dalziel K, Makin G 1992 Assessment of cleansing, debridement, dressings, contact sensitivity, new one-layer adhesive bandaging method in training/education and quality assurance. maintaining prolonged limb compression and effects Roe BH, Luker KA, Cullum NA, Griffiths JM, on venous ulcer healing. Phlebology; 7:59-63. Kenrick M 1993 Assessment, prevention and Trengove NJ, Stacey MC, McGechie DF, Mata S monitoring of chronic leg ulcers in the community: 1996 Qualitative bacteriology and leg ulcer report of a survey. J of Clin Nurs; 2:299-306. healing. J of Wound Care; 5(6):277-280. Rubin J, Alexander J, Plecha E et al 1990 Unna’s Waddell G, Feder G, McIntosh A, Lewis M, boot vs polyurethane foam dressings for the Hutchinson A 1996 Low Back Pain Evidence treatment of venous ulceration. A randomized Review. London: Royal College of General prospective study. Arch Surg; 125:489-90. Practitioners. Sachine-Kardase A, Bardake Z, Basileiadou A, Walshe C 1995 Living with a venous ulcer: a Dimpinoydes, Ouxoyne A, Patse O 1992 Study of descriptive study of patients’ experiences. Journal clean versus aseptic technique of tracheotomy care of Advanced Nursing; 22(6):92-100. based on the level of pulmonary infection. Noseleutike; 31(141):201-11. Yang D, Morrison BD, Vandongen YK, Singh A, Stacey MC 1996 Malignancy in chronic leg ulcers. Scottish Intercollegiate Guidelines Network: The care Med J Aust; 164:718-721. of patients with chronic leg ulcer. SIGN July 1998. Scriven JM, Hartshorne T, Bell PRF, Naylor AR, London NJM. Single-visit venous ulcer assessment clinic: the first year. Br J of Surg 1997; 84:334-336. 18 The management of patients with venous leg ulcers References
Sources of Further Information Useful contact addresses: Quality Improvement Programme Information Service Tissue Viability Society RCN Glanville Centre 20 Cavendish Square Salisbury district Hospital London W1M 0AB Salisbury SP2 8BJ. Tel: 020 7647 3831 Tel: 01722 336262 http://www.rcn.org.uk 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 Health Care 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 The management of patients with venous leg ulcers Sources 19
Appendix 1. Documentation Development of review criteria Based on the national clinical guideline for leg ulcer management (RCN et al 1998), the review criteria were developed according to a method developed by researchers in the Clinical Governance Research and Development Unit (Baker et al 1995; Fraser et al 1997) The method involved: ◆ identification of the key elements of care ◆ focused systematic reviews based on the national clinical practice guideline (RCN et al 1998) and justified by evidence ◆ taking into account consensus based recommendation considered to have an important impact on outcome ◆ presentation of the criteria in a protocol. The standards A standard in this audit protocol refers to the level of performance for each criterion, to which community nurses are aiming. The purpose of criteria and standards is to assist in the improvement of care. The ultimate aim for most of the criteria is the achievement of a standard of 100%, although it is recognised that there may be perfectly acceptable reasons for falling short of this level on some occasions in relation to some criteria. 20 The management of patients with venous leg ulcers Appendix 1: Audit Form
Appendix 2. Nursing Management of Venous Leg Ulcers in the 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/is referred/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 Form 21
Appendix 2. Nursing Management of Venous Leg Ulcers in the Community: 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 r other – list no more than five products __________________________________________________ Q10. Which dressings were used? Hydrocolloid ❑ Foam ❑ Alginate ❑ Tulle gras ❑ NA Tricotex r other – 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 40 ❑ (excluding travel time) 22 The management of patients with venous leg ulcers Appendix 2: Audit Form
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, patients who are in the process of treatment and patients who have a recurrent ulcer. This retrospective audit will include patients with venous leg ulcers under your care at the present time. All patients who participate in the audit 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 patients with venous leg ulcers at the start of the audit. Questions 5 to 14 should be completed at the end of the audit or 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’s case 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-up questions 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 case records. The no box ticked if there is no medical history documented (if a patient does not have a history of relevant medical conditions for example, vascular disease, coronary heart disease etc, it must be documented at the assessment visit). BP, urinalysis, weight - the yes box should only be ticked where those items were undertaken 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 the date of assessment and the level of ABPI. If a Doppler machine is not available in the team or practice or for any 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. Please indicate how you measure ulcer size normally. If you use any other method of measurement, please tick other and state the method you have used. If the patient has more than one ulcer on both legs, please describe ulcer two 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 the assessment visit. For analgesia, the yes box should be ticked when the patient has received analgesia from any professional. Form Q 5. Referral If the patient needs to be referred to a specialist, please give the date of referral, the main reason for referral and tick the type of specialist to which you have referred your patient. For most practices, the referral will go to the GP first. In this situation, please tick GP and also tick any other specialist to which you consider the patient 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 Form 23
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 than one type of bandage if necessary. For other, please do not list more than five products. If the patient was not suitable for high compression (for example, acute heart failure, rheumatoid arthritis, grossly distended leg or any 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 more than 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). If the patient has more than one ulcer or ulcers on both legs, please describe the outcome of ulcer 2 or add ulcer 3 if necessary. Q13. Prevention of recurrence For patients who have received education on compression stockings, the yes box should only be ticked if this has been documented. If the ulcer is not healed by the end of the audit, or is not suitable for compression stockings, 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 of the 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 sent back to the project leader in your organisation. Please make a photocopy of each form before sending it. 24 The management of patients with venous leg ulcers Appendix 2: Audit Form
The management of patients with venous leg ulcers Notes 25
26 The management of patients with venous leg ulcers Notes
RCN Members £3.50 Non RCN Members © Copyright 2000: Royal College of Nursing. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or £4.50 transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise, without prior permission of the Publishers or a licence permitting restricted copying issued by the Copyright Licensing Agency, 90 Tottenham Court Road, London W1P 9HE. This publication may not be 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 the ISBN 1-873853-89-0 prior consent of the Publishers. Publication code: 001 269
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