A Literature Review: Venous Ulcers to Heal or Not to Heal

110 Journal of Tissue Viability 1992 Vol. 2 No 4

A LITERATURE REVIEW: VENOUS ULCERS TO HEAL OR NOT TO HEAL PATRICIA BURTON

District Nurse, Community Unit, Walsall Health Authority INTRODUCTION The causative factor leading to venous ulceration appears to be the laying down of fibrin around the dermal capillaries, which reduces oxygenation to the tissues resulting in local ischemia and tissue damage. The onset of ulceration is characterised by pigmentation of the skin, dilated subdermal venulesand induration of the subcutaneous tissue. It is therefore apparent that the slightest injury to the fragile tissue will lead to ulceration. The wealth of literature available on the treatment of venous ulcers by various disciplines, e.g. medicine, dermatology, pharmacology, nursing etc., suggests the extent of the problem. However, included in their treatments is a procedure common to all, that of compression bandaging 1• 2• 3•4 • 'Compression implies the deliberate application of pressure in ordertoproduceadesiredclinicaleffect' 5 • Thisisusuallyachieved by the appropriate bandaging or elasticated stocking, which applies pressure to the underlying skin and tissue, giving support to the superficial veins, reducing capillary pressure, thereby preventing oedema. The use of compression bandages dates back to the ancient Egyptians. In the 17th Century, the use of controlled compression in the treatment ofleg ulcers was acknowledged by the use of rigid lace up stockings. The first elasticated bandage was manufactured in the mid 19th Century with an article appearing in the Lancet in 1878 on the use of the bandages in the management of varicose veins 6•

product to be tested to the legs of volunteers, after which the pressure exerted by each bandage at the calf muscle was measured by a pneumatic sensor linked to a pressure gauge. Fresh samples of each bandage were then scientifically stretched and tested by means of a tensiometer determining the pressure exerted, force required, extensibility and ability to maintain applied pressure. Data showed considerable variations in performance, not only between the different types of bandages, but between different manufacturers. Crepe bandages performed badly losing between 40% and 60% of their tension within 20 minutes, whereas Elastic Web lost approximately 20%. From the findings of the study, the investigator was able to indicate the categories to which each bandage belonged. (High compression - Blue Line, medium pressure -Elastocrepe), and that Tubigrip was a useful product where low pressures were required, indicating that many compression bandages in common use are incapable of producing or sustaining effective pressure. A further study assessing the efficiency ofa compression bandage was undertaken by a highly qualified registered nurse, a surgical consultant and registrar9 • They assessed the below knee pressures exerted by one commonly used bandageareandpost washing and used in combination with a paste bandage. Ambulatory pressure exerted by the bandage was measured by a sensor and pressure transducer, designed by Professor Borgnis, applied at various points around the leg.

The pressure to be exerted upon the leg is very much dependent on the condition to be treated. However, it is now accepted that a pressure gradient ankle to knee should be produced with the greatest degree exerted at theankle7 to significantly increase blood flow. Although debate regarding optimum levels persists, it is generally accepted that pressure of approximately 30 - 40 mmHg at the ankle graduated to 15- 20 mmHg at the calf is adequate.

The sample consisted of healthy volunteers. Preliminary assessments of the spiral bandaging techniques recommended by the manufacturers revealed that ankle to knee pressures were insufficient A figure of eight technique, a method favoured by surgeons for controlling haemorrhage and oedema following varicose vein surgery, was employed, which provided more compression at the gaiter area and improved overall graduated compression. In order to eliminate a possible variable, the Elastocrepe bandages were applied by one operator. Measurements were recorded and repeated at predetermined time intervals and bandages were washed following a standard procedure. The combined paste bandage and Elastocrepe bandage trial was governed by the same consistent requirements. The results of this quantitive study showed that thirty minutes after application of the Elastocrepe bandage, pressure at the ankle fell from 44 mmHg to 37 mmHg and following washing, fall off was rapid, dropping to 29 mmHg after 30 minutes, rendering them useless. The trial involving the Viscopaste and Elastocrepe bandages indicated that the combination produced a higher initial pressure, a much slower fall off and maintained a higher level of compression than Elastocrepe alone.

Thomas8 , a principal pharmacist, described a comparative study using a variety of extensible bandages in common use including Tubigrip. Experienced nursing staff applied samples of each

The importance of sustained pressure at a given level has led to increased interest in the quantitive evaluation of certain bandages on drug tariff. The Bio Engineering Unit at Strathclyde University9

REVIEW OF LITERATURE As a large proportion of the author's working day is involved in treating leg ulcers, it was her wish to examine the literature published on the efficacy of compression bandaging in the management of venous ulcers. However, it soon became evident that although the use of compression therapy for treatment of varicose ulcers is now well established, the vast majority of literature relates to quantitive evaluation and classification of available bandages, and that only one major piece of research relates pressure to the healing rate of venous ulcers.

Journal of Tissue Viability 1992 Vol. 2 No 4 111 undertook tests to assess the interface pressure beneath elastic bandages during the activities of daily living over a prolonged period. Pressures were recorded on a data logger, and a meter also determined the posture of the leg. The bandages evaluated were Granuflex, Lestreflex plus Viscopaste and Elastocrepe plus Viscopaste. A pressure sensor was positioned on the leg of each subject in identical places and bandages applied at 50% extension by a single trained bandager. The subjects were required to fulfll certain activities 3 hourly and keep a diary of daily living activities. Data was collected every 24 hours over a continuous period of seven days. All bandages showed an initial fall in pressure, generating highest pressures in the standing position. Overall the Granuflex bandage responded significantly to activity and posture, remaining undisturbed at the end of seven days and provided sustained compression throughout. The Lestreflex responded to posture changes but both Lestreflex andElastocrepe were disrupted before the end of the trial. The data once again proved the inadequacy ofElastocrepe as a compression bandage. The three articles, spanning a period of ten years, identified their objectives from the outset, were authoritative, providing factual information supported by figures and statistics, all arriving at the same conclusion, that compression bandages in common use and available on FP10 performed inadequately and in some cases were useless. Their searches of the literature relating to effective compression bandaging, though empirical and international, identified the limited amount available, all three articles often using the same references. Whilst unqualified to argue with the scientifically obtained data, one observes that the subjects of the studies were always healthy individuals and from pictorial evidence, po~sessors of well proportioned limbs, bandaged by one experienced operator. One could question whether the results would have been as convincing in an everyday situation, on large disproportionate limbs, bandaged by different operators. The articles, identified the need to improve venous return by adequate support in the treatment of venous ulcers and highlighting the inadequacies of commonly used bandages. One could question the value of the research, as little has changed since the earlier study was undertaken. This suggests an inability to relate research to practice, and a lack of interest by professionals of all disciplines to bring about the required changes. However, a positive aspect of the research is the identification of newly developed bandages, their benefits and the interest within the companies to develop a compression bandage that is able to fulfil the role of overall compression, demonstrated by Article Three. All three studies neglected to state the size of their volunteer population and time span covered, appearing relatively short. One speculates, particularly where Article Three is concerned, whether this is because the desired result has been achieved. I would suggest that the particular study was motivated by the manufacturers of the trialed Granuflex bandage. The inclusion of an Elastocrepe bandage in the trial, recognised for the past ten years as inadequate as a compression bandage, gave an unfair advantage to Granuflex, a manipulative move.

Whilst these articles are of value to professionals of various disciplines involved in the treatment of varicose ulcers and with an interest in empirical research that proves the therapeutic value of certain treatments, some of the data is confusing and written for a particular audience. In order to obtain the therapeutic value of compression bandaging, all three studies reiterated the need for use of the correct compression bandage and technique, consistency of bandaging by the operator, trained and experienced in the practice. The importance of sustained compression in the healing of chronic venous ulcers was demonstrated by a senior surgical registrar, and colleagues11 , who described a major randomised comparative study of a non occlusive dressing (N A dressing), an occlusive dressing (Granuflex) and an anti-bacterial dressing (Flamazine) in the treatment of 120 similar sized chronic venous ulcers of mean duration of 26.25 months, over a twelve week period. Prior to randomisation to exclude ulcers of arterial origin and those larger than 10cm, a history, assessment of arterial sufficiency and calculation of size were made. A standardised bandaging technique was employed using a four layer system, developed in a research based venous ulcer clinic in the South East, which produced high pressure graduated compression. Data was scientifically analysed weekly and each group compared using a chi-squared test. The results showed that within the three groups there were no statistical differences in healing rates, a total of 73% healed within twelve weeks. Theauthorattributedtherapidhealingratetothecarefullyapplied graduated compression bandaging, concluding that the primary dressing had no influence, and recommended that weekly cleansing, dressing with a simple cheap non-adherent dressing and adequate sustained compression, were the requirements for healing most venous ulcers. AsurgeonmemberofBlair'steam,McCollum12,descnbedafurther comparative study over twelve weeks, including as part of the larger randomised study, of the four layer bandage system with traditional adhesive plaster bandaging in terms of compression achieved and healing of venous ulcers in 126 consecutive patients, mean age 71 years with chronic venous ulcers that had resisted treatment with traditional bandaging for a mean of 27.2 months. The same protocol for exclusion from the study was employed. Mechanical measurements of pressure of both systems were subsequently made on twenty consecutive patients at identical sites. The adhesive plasters were applied by the staff who usually did so, and the four layer system by it's proposers. Data was recorded initially 4, 8, 24 hours and 1 week post bandaging and weekly measurements of the ulcer margins traced, from which the overall area was mathematically calculated. Again the four layer system produced higher ankle pressures of42 mmHg which were maintained over the week, the compression beneath the traditional ~ystem deteriorated rapidly and after twenty four hours fell to 10.4 mmHg, confirming the inadequacy of the system. Atweektwelveofthestudy, 110of148 ulcers, 74% healing was achieved.

112 Journal of Tissue Viability 1992 Vol. 2 No 4 The results identified the dependency of the traditional system on technique of application to exert compression, whereas the four layer system exerted compression automatically when the same tension and overlap were used, as the radius of the leg increases ankle to calf. The author's objectives, in both studies were presented in a concise resume in the introduction to these easy to read papers, achievement of objectives being identified by dependable factual information. I would suggest that the studies were developed from inductive theories and conducted in an atypical controlled environment, with a sample of mobile, motivated subjects which enhanced the desired result. Complete randomised sampling was maintained throughout the studies12 stated that it's success was suggested by the similarity of the three groups. Randomised sampling does not avoid bias as there is no guarantee that the sample is truly representative. The studies were valuable in that they confrrmed that healing of chronic venous ulceration could be achieved by a simple primary dressing and sustained graduated compression in a cost effective manner and that the traditional bandaging systems are inadequate andcouldbereplacedbybandagesstillunavailableonformFP10. Interestingly enough, none of the bandages used in the four bandage system would be classed as compression when used singly, but in combination achieved the required pressure. Additionally, only one of the bandages used is available on FP10, implying further experimentation and research into combination bandaging with those available. Although techniques used in the studies were employed in a clinic setting, they could be easily adapted for community settings. In a pilot study ofa small community ulcer clinic, funded by grant, functioning in close co-operation with the vascular services of the large London hospital where the previous studies were centred, a small study described by Moffatt13, a district nurse with a particular interest in venous ulceration, was conducted with 21 patients; mean age 73, 16 of whom had chronic venous ulcers of average duration of 21 months, using protocols, procedure and findings of the previous studies. Within six weeks 14 (84%) were completely healed, the remainder healing within four months. The population was obtained by convenience sampling, some by self referral, and consisted of double the usual female ratio, immediately identifying it as unrepresentative. The sample were extremely compliant, suggesting high motivation and keen interest which would further enhance healing rates. Although the study is too small to be important in planning future policies, it serves to reiterate the importance of sustained graduated compression in the treatment of venous ulceration. Compression, the single most important measure in healing most venous ulcers, is not a treatment in isolation. One should never lose sight of the patient, employing an holistic approach to assessment, care and treatment as cited by Milward14• CONCLUSION Each study lends invaluable support to the theory that sustained graduated compression will heal most venous ulcers, begging the

question, why do they remain a major health problem and drain on N.H.S. resources? The literature identifies that compression bandaging is an art, requiring skill, training, assessment and initially supervision, as poor application can be detrimental to the patient. Bandaging is no longer part of a nurse's education. For all nurses requiring the skill, there are implications for post-basic education and assessment in accurate assessment, using doppler ultrasound, bandage selection and application using the correct techniques. With the advent of nurse prescribing, this will be one of the clinical areas most affected by accountability. There are also implications for further research in bandaging practices and combination bandaging. Comwall 15 identified that compression bandaging techniques in Europe were completely different to our own, using non -stretch bandages exerting higher pressures. This too suggests further research and availability of a range ofbandages. It will be interesting to see whateffectE.E.C. standards have after 1992 on the availability of compression bandages. Attention should firstly be addressed to the theory/practice gap. Poor communication of the findings often prevents them from being implemented. When research directly addresses practice in a particular field it usually requires the practitioner to search for it and interpret it. Reflecting on the time factor element and often the lack of enthusiasm of staff, literature reviews and specialist resource centres can help facilitate this need. Research and practice are supportive to each other. Through it we are provided with the knowledge and framework to improve nursing practice and quality of patient care. As practitioners, we should be endeavouring to implement these fmdings, but unavailability of resources prevents us from doing so. Supported by the research findings, through our various pressure groups we should be lobbying for a wider range of compression bandages to be made available on FP 10, the benefits of which would be realised by all in the savings made. Although all available literature appears conclusive in supporting the compression theory, none disproving it, further large comparative studies relating pressure to the healing rate of venous ulcers may be necessary to convince the policy makers. ADDRESS FOR CORRESPONDENCE Mrs P A Burton, Pool Street Clinic, Pool Street, Walsall WS1 2EN REFERENCES 1 Robinson B. Clinical considerations in the use of compression therapy in the community. CARE-Sci & Pract, 1990; 8: 70-1. 2 BlairS D, Wright D D I, Blackhouse C M, Riddle E, McCollum C N. Sustained compression and healing of chronic venous ulcers. BMJ, 1988; 297:1159-61. 3 Gibson B. Use of compression in the treatment of leg ulcers. CARE-Sci & Pract, 1990; 8:67-9. 4 Thomas S T. Cost effective management of leg ulcers. Community Outlook, 1990: March; 21-2.

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5 Thomas S. Bandages and bandaging, the science behind the art. CARE-Sci and Pract, 1990; 8: 56-60. 6 ThomasS. WoundManagementandDressings, 1990; 13: 88-98. The Pharmaceutical Press. London. 7 Jones N A et al. A physiological study of elastic compression stockings in venous disorders of the leg. Brit J Surg, 1987; 67:569-72 8 Thomas S, Dawes C, Hay P. A critical evaluation of some extensive bandages in current use. Nursing Times 1980; 76. 26. 1123-6. 9 Dale J, Callam M, Vaughan Rucldey C. How efficient is a compression bandage? Nursing Times, 1983; 79: 49-51. 10 Sockalingham S, Barbenel J C, Queen D. Ambulatory

11 12 13 14 15

monitoring of the pressures beneath compression bandages. CARE-Sci and Practice, 1990; 8: 75-9. Blair S D, Blackhouse C M, Wright D D I, Riddle E, McCollum C N. Do dressings influence the healing of chronic venous ulcers? Phlebology, 1988; 3, 2, 6: 129-34. McCollom C N, BlairS D, Blackhouse C M, Wright D D I, Riddle E. Sustained compression and healing of chronic venous ulcers. Brit Med J, 1988; 297: 1159- 61. Moffatt C J. Community venous ulcer clinics. A new approachtohealing. PrimaryHealthCare, 1989; 7,6.14-6. Milward P. Not just an ulcer. J Dist Nurs, 1988; 10: 4-5. Cornwall J. Venous ulcers and compression. Journal of District Nursing, 1988; 9: 4-6.

THE SYMPOSIUM ON ADVANCED WOUND CARE GERRY BENNETT Consultant Geriatrician, Department of Health Care for the Elderly The Royal London Hospital The 5th Annual Symposium on Advanced Wound Care (and the Medical Research Forum on Wound Repair) was held in New Orleans, Louisiana, USA, between April 23-25, 1992. New Orleans proved a wonderful backdrop to this highly successful conference. Conference delegates were able to get a glimpse of the famous French Quarter, Superdome and of course the Mississippi river. In addition the city is the US's acknowledged gastronomic centre with magnificent Cajun and Creole cuisine.

to Ms Maya Morison for her poster Quality Assurance and Wound Care in the Community: An Innovative Solution to Some Problems Identified. This professional looking poster outlined an audit process resulting in a Wound Management Policy and local product formulary being developed together with a computer assisted learning package to update staff on the latest methods for leg ulcer patient assessment and management. It so impressed the poster judges, it was awarded a commendation rosette.

The Symposium organisers subtitled the event 'Collaboration in Practice' and had declared objectives for attenders:-

The jointly held 2nd Medical Research Forum on Wound Repair again appeared to emphasise the role that growth factors will play in wound care in the future. In one presentation an Activated Platelet Supernatant Topical (APST) was prepared from homologous platelets and contained multiple growth factors including PDGF, EGF, PF-4, TGF-B, aFGF and bFGF. This supernatant was topically applied to a series of non-healing leg ulcers in diabetic patients. APSTsignificantly accelerated wound closure in diabetic leg ulcers when administered as part of a comprehensive program for the healing of chronic wounds. Another new concept was of an "intelligent" wound dressing. The authors claim it is possible to develop a wound dressing which automatically responds to a wound's exudate level by self adjusting its moisture vapour transmission rate (MV1R). This technology has developed a triaminate composite consisting of a macroporous adhesive, an absorptive asymmetric membrane and a hydrophilic polyurethane film. This dressing provides a five fold MV1R adjustment as a function of exudate level.

Differentiate between the microbial status of a wound. Examine trends in wound theory and research. Explore wound coverings and clinical applications. Discuss current medical, surgical and nursing treatments in wound management. A Pre-Conference Seminar on the Biology of Wound Repair addressed on this subject by Dr Warren L Rothman heralded the proceedings proper. The conference was opened by Evonne Fowler- the Symposium Chairperson, followed by three days of varied, interesting and on occasions provocative papers. The UK was extremely well represented by its invited speakers. They included Mr Michael Callam (Wound Care- Who Cares? I Skin Grafting I Pinch Grafting ), Dr Terence Ryan (Pneumatic Compression), Mr John Scurr (Vascular Disease and Extremity Ulcers: Importance of Diagnosis and Pathophysiology), and Ms Sue Bale and Dr Raj Mani. Dr Keith Harding- Cardiff Wound Healing Unit was a Faculty Member and Chairperson for the Clinical Research Abstracts. The poster sessions were held in a large hall with again the UK having a large presence, especiallymembersofthe Tissue Viability Society. Posters included: The Tissue Viability Society: a UK Multidisciplinary EducationalResource(DrG Bennett), Teaching on Chronic Wound Care in the UK Medical Undergraduate Curriculum: A Survey (DrG Bennett), The UseofProtectiVe Skin Wipes Under Adhesive Strapping (Mrs Carol Dealey), The Role of Adequate Dressings in Hospital and Home Healthcare (Mrs Pam Milward, Ms Carol Dealey). Pride of place howevermustgo

The Symposium guide with abstract details is available via the Society's office (Tel. 0722 336262 ext 4057). The sixth Annual Symposium on Advanced Wound Care is being held in the Hyatt Regency, San Diego, California, USA, April18- 20, 1993. For further information contact Health Management Publications Inc, (TVS for telephone and Fax numbers). ADDRESS FOR CORRESPONDENCE

Dr G Bennett, Consultant Geriatrician, Department of Health Care for the Elderly, The Royal London Hospital (Mile End), The Bancroft, Bancroft Road, London, E1 4DG