Evaluation of Urgotul® plus K-Four® compression for venous leg ulcers

In this non-comparative clinical evaluation, 36 subjects with venous leg ulcers, 85% of which were indolent or deteriorating, were treated with Urgotul® lipidocolloid wound dressing and the K-Four® multilayer compression bandaging system for 12 weeks or to healing –– whichever occurred first. Results show that Urgotul® was an ideal dressing in combination with K-Four®‚ being easy to apply (98.7%) and remove (98.1%), and largely pain-free (95.6%) and non-adherent (99.7%). In a patient group of ‘hard-to-heal’ ulcers, 50% of the ulcers healed within the treatment period. Ulcers not healed after 12 weeks achieved almost 50% area reduction on average. The treatment combination proved safe, with only one of seven adverse events reported being probably related to the products used. This study supports the use of a combination of Urgotul® dressing and K-Four® compression to provide a ‘matched’ treatment for venous leg ulcers. Compression bandaging remains the basis of venous leg ulcer management (Moffatt, 1995), and is regarded as the therapy of choice (Alexander House Group, 1992). The provision of graduated, sustained compression (with a sub-bandage pressure of 40 mmHg at the ankle, reducing to 17 mmHg below the knee) is generally regarded as satisfactory and will support healing (Simon, 1996). It is widely accepted that this goal is routinely achieved through the correct application of multilayer bandaging systems (Taylor and Taylor, 1999). A wide variety of healing rates are reported by advocates of the various bandaging systems, ranging from 30% (Cornwall et al, 1986) to around 70% (Moffatt et al, 1992). However, healing rates must be interpreted in the context of the relevant characteristics of both the patient and his/her wound, as these may favour or compromise healing. Following an analysis of the relevant literature, a recent Cochrane review (Cullum et al, 2003) reported on the effectiveness of compression bandaging in the treatment of venous leg ulcers. Selected findings included ‘compression was more effective than no compression’ and ‘there was no statistically significant difference in healing rates between multilayered systems’. At face value these are fair and reasonable findings. However, there are parameters that are worthy of consideration if comparisons of efficacy between bandaging systems are to be made. The vagaries of bandaging (Taylor and Taylor, 1998; Reynolds, 1999), including poor knowledge and technique, should not be a factor as these studies were conducted in specialist centres where the expertise available is indicative of the quality of the skills available. However, one factor that may impact on healing rates is the duration of the ulcer before study entry. This factor is noted by Vowden et al (2001), who recorded ulcer duration of patients entered into two studies. In the first study, which compared healing rates of three multilayer compression J Smith, J Hill, S Barrett, W Hayes, P Kirby, S Walsh, E Gittins, F Whitehurst, R Cooper systems, ulcer duration was 112, 142 and 177 weeks. In the second, non-comparative study, ulcer duration was 205 weeks. These served to compromise healing as if an ulcer or a group of ulcers have a long history of non-healing then by definition resolution will be more difficult to achieve when compared with an ulcer that has a history of 12 weeks or less. Other factors that may influence healing rates include size of ulcer, concurrent additional pathologies and ankle/ brachial pressure index (ABPI). Variation in ulcer size was recognized as an independent variable by Meyer et al (2002). In this study, ulcers were stratified and randomized within one of three size groups when comparing healing rates of two different three-layer bandaging systems. In recent years, wound pain has become a focus for those responsible for leg ulcer care (Hollinworth and Collier, 2000; Moffat et al, 2002). In particular, it is now accepted that venous leg ulcers are frequently the source of considerable pain, which impacts on patients’ lives (Rich and McLachlan, 2003). While some of this pain is of endogenous origin, the dressing change procedure, including dressingrelated trauma, is also a major contributor. Historically, little consideration has been given to the role of the dressing in the management of venous leg ulcers with high compression. In terms of healing rates, this view is no longer appropriate. Stacey et al (1997) have demonstrated that the wound contact layer, when correctly selected, can have a positive influence on healing. Given our understanding of ulcer pain and the role of dressings, this becomes a critical aspect of care. Jacqueline Smith is Tissue Viability Nurse, North Dorset Primary Care Trust, Jayne Hill is Community Nursing Sister, North East Wales Trust, Simon Barrett is Vascular Leg Ulcer Specialist/Lecturer Practitioner, Hull & East Yorkshire NHS Hospital Trust, Wendy Hayes is Vascular Nurse Specialist, Worcestershire Acute Hospitals NHS Trust, Pamela Kirby is Lead Nurse Vascular/Tissue Viability Team, Sherwood Forest Hospitals NHS Trust, Sally Walsh is Tissue Viability Nurse, Central Cheshire Primary Care Trust, Eleri Gittins and Fran Whitehurst are Tissue Viability Nurses, Conwy & Denbighshire NHS Trust, and Robin Cooper is Wound Care Specialist, North Hampshire Primary Care Trust Accepted for publication: January 2004