Last updated: Jun 2006
Keywords: compression bandaging; chronic venous insufficiency; wound healing; venous ulceration; clinical reviews; evidence-based practice.
A wealth of evidence on the efficacy of four-layer compression bandaging in treating venous leg ulcers has been accumulated over the past decade.
This review of the evidence base confirms the value of four-layer compression bandaging in improving outcomes for patients with venous and lymphatic disorders.
Further cost-effectiveness studies are required to evaluate the many different four-layer bandaging systems in use.
Four-layer bandaging has been in existence for more than 15 years, during which time it has been used in numerous studies and in many populations throughout the world. This short series reviews the development of the four-layer compression bandage system, together with the evidence that contributes to a greater understanding of why it is effective in promoting healing in venous leg ulcers. This article, the third and final in the series, looks at the evidence base for efficacy in treating venous leg ulcers.
Over the past decade many studies have demonstrated how four-layer bandaging improves outcome in patients with venous leg ulcers, with increased healing rates, improved quality of life and greater cost effectiveness    . A wide range of research methodologies has been used. While randomised controlled trials (RCTs) remain the gold standard for demonstrating clinical effectiveness, critics often comment that the patients recruited for such trials are not truly representative of routine clinical practice as those with difficult-to-heal or complex ulcers are usually excluded. Nevertheless, numerous cohort studies have shown the value of four-layer bandaging in everyday practice               .
Six years ago, a systematic review of RCTs on compression identified 22 studies that fulfilled the rigorous entry criteria . Each trial was awarded a quality grade and the relative risk and 95% confidence interval was calculated for each.
As in many areas of wound care research the quality was poor, with small sample sizes and short follow-up times. The outcomes of the trials varied, with some measuring outcome by a decrease in ulcer size rather than the agreed standard of complete healing of the reference limb. Issues such as the criteria for judging when complete healing had occurred and the lack of a blinded outcome also make it difficult to compare studies. Few trials described the method of bandage application. In addition, some patients were treated by specialist practitioners while others were seen by general staff. Inclusion and exclusion criteria differed between the studies and reasons for withdrawal and recurrence rates were often unreported.
A number of studies in the systematic review involved the Charing Cross and Profore systems         . The 12-week healing rates in these studies vary dramatically   . Many of these differences can be explained by examining the risk factor profiles in the different studies. Factors such as the size and duration of the ulcer, as well as the trial entry criteria, will influence the outcome.
After a review, Fletcher et al  concluded that multi-layer systems are likely to be more effective in achieving healing than single-layer systems. However, there remains a paucity of studies that have examined single-layer systems adequately.
Numerous studies have used four-layer bandaging systems in different populations and new European studies are being reported  .
The original study using four-layer bandaging by a hospital service set a benchmark healing rate of 74% at 12 weeks . The results from the Riverside Community Leg Ulcer Project, the first attempt to develop an integrated leg ulcer service, confirmed that high healing rates were possible when care was provided in a community setting . Other authors have reported similar findings .
The Riverside study also began the process of risk factor analysis in order to identify independent factors that influenced healing . Ulcer characteristics, such as duration and size, have all been used to predict whether healing will occur . In addition, factors such as limb mobility and fixed ankle joint have been shown to significantly influence outcome . The Riverside study took a wider, epidemiological perspective in identifying social factors, independent of clinical status, that delayed healing, such as central heating, living alone and being male. While authors often analyse their healing rates using known risk factors, little research has sought to identify other factors that may affect outcome . Low healing rates have been recorded in a number of community studies  and it is possible that issues such as the clinician's level of expertise and bandaging skills may influence outcome.
Healing rates have also been shown to improve over time . However, a number of studies have selected patients for inclusion rather than treating the entire population, and hospital-based studies are likely to show a population bias when compared with leg ulcer patient profiles within a defined geographical area.
Comparisons between different cohort studies using four-layer bandaging are complicated by all the above issues.
McKirdy et al reported on the use of four-layer bandaging in the treatment of patients with pretibial lacerations . These wounds can be difficult to heal and often require skin grafts. Oedema and poor vascular perfusion in this area of the leg contribute to poor healing. However, compression was found to increase healing rates significantly compared with the use of wound dressings alone .
A recent large RCT has shown further evidence of the value of introducing high compression therapy into routine practice . In this study the control group's healing rate was slightly higher than in other control populations . This may have been due to the routine use of compression in the control population and the increasing knowledge of its importance as the trial progressed, which influenced the choice of products in the control group. This study also confirmed the considerable cost savings associated with the introduction of multi-layer bandaging .
Other studies have reported the successful use of multi-layer systems in patients with complex ulceration involving conditions such as diabetes mellitus . Arthur and Lewis  also report the use of reduced compression in patients with concurrent peripheral vascular disease. Out of a total of 24 patients, 19 (74%) healed. Two patients were withdrawn because of deteriorating arterial disease. As would be expected, the highest rate of healing occurred in those who had angioplasty or arterial reconstructive surgery . These studies raise issues concerning the wider use of compression when oedema is an accompanying problem in other wound types.
A trial comparing four-layer bandaging with a two-layer bandaging system failed to show a marked difference in healing at 24 weeks using intention-to-treat analysis . However, the significance of this result is obscured by the very high withdrawal rate in the two-layer bandaging arm (54%) due to bandage-related adverse events. Time to healing was faster in the four-layer arm of the study. This study raises issues concerning the importance of recording all data from studies, including withdrawal rates, those lost to follow-up, and patients who are screened but are not suitable for the trial . Only then can a comprehensive picture emerge.
A multi-centre trial of four-layer bandaging and inelastic (short-stretch) bandaging carried out in The Netherlands and Austria involved 112 patients. It found no significant difference in healing rates at 16 weeks using intention-to-treat analysis between the two groups . In discussing the implications of this study Partsch et al raise a number of issues concerning compression trials .
Differences in outcome were found between centres and practitioners' familiarity with inelastic regimens may have affected this. Partsch et al suggest that the ease of application of a multi-layer bandaging system may be of increased importance when patients are treated in the community rather than in specialised hospital centres where there is considerable expertise . This study also confirmed the importance of stratifying ulcer size at randomisation to the trial because of the effect that size and duration have on the outcome.
During the past few years a number of other multi-layer bandaging systems have been developed based on the original concept    . Bandage testing has revealed some minor differences in bandage performance and characteristics  . The original Charing Cross system has been compared with other multi-layer bandaging systems in a large (n=232) RCT. No significant differences were found at 24 weeks, although a minor benefit was noted at 12 weeks in the latter multi-layer bandaging system group  . Vowden et al evaluated the healing rates of a multi-layer bandaging system in a non-comparative study and found a healing rate of 53% at 12 weeks , which is consistent with other studies.
Clinical problems such as latex allergies have been addressed, so the main differences between the new systems are likely to relate to cost. However, all of the new systems should be subjected to rigorous RCTs before it can be claimed that their performance is equal to that of the four-layer systems that have been more widely researched. Many evaluations of these new products focus on patient and professional acceptability, which is of great importance but does not confirm clinical efficacy.
Few leg ulcer studies have incorporated an analysis of their cost effectiveness and most evidence on this relates to one particular four-layer system. Carr et al developed a cost model using results from published studies . They suggest that failing to use the most cost-effective treatments, thereby creating inefficient services and wasting NHS resources, could amount to a loss of between £350,000 and £1.08m annually in a typical health authority. Other authors have shown that introducing multi-layered bandaging is highly cost effective, with the greatest savings to be made in nursing time    . Studies often fail to incorporate this issue, despite the move towards cost-effective evidence-based care, and further research on cost effectiveness is required to evaluate the many different bandaging systems in use.
There can be few wound care products with a greater research portfolio than four-layer bandaging. The wealth of evidence accumulated over the past decade confirms its value in improving outcomes for patients with venous leg ulcers. Before the development of the four-layer system, venous ulcers often failed to heal and patients reported decades of unrelenting suffering. In addition to greatly improved clinical outcomes, research confirms that improvements in patients' quality of life are associated with ulcer healing. In increasingly consumer-led health systems these issues will become of central importance as patients become more empowered and knowledgeable, and demand the most effective care.
The acceptance of four-layer bandaging systems by practitioners in clinical practice is affected by a number of factors. The system is applied with relative ease after training and is not subject to the variations in performance seen in some other bandage systems, which require more training and greater expertise .
Despite these advances many patients do not receive optimum care. Compression therapy will only reach its full potential if it is placed within an effective multidisciplinary service  . Compression treats the symptoms of ulceration, but practitioners must continue to strive to understand and eradicate the causes of venous ulceration. In the meantime, effective compression systems such as the four-layer bandaging system will remain the cornerstone of the management of venous and lymphatic disorders.
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