A randomised controlled 8-week crossover clinical evaluation of the 3M Coban 2 Layer Compression System versus Profore to evaluate the product performance in patients with venous leg ulcers.

This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL.

Why patients do not comply with compression bandaging.

The aim of this study was to explore the perceptions of patients presenting with venous leg ulceration who were labelled as 'non-compliant' with compression bandaging by district nurses. A hermeneutic approach was taken and 14 patients with chronic venous leg ulceration were interviewed. Six themes emerged from the data: (1) lay perceptions of the cause and healing of leg ulceration, (2) concurrent problems of leg ulceration, (3) dilemmas of treatment, (4) perceptions of healthcare professionals, (5) the need for health education, (6) what it is like living with a leg ulcer. Patients did not have a clear understanding of their condition or treatment regimes. Concurrent problems associated with compression bandaging included pain, leakage of exudate and skin irritation, and these symptoms adversely affected patients' lifestyles and contributed to 'non-compliance'. Patients acknowledged that acceptable care was given in the community. However, they said that healthcare professionals misunderstood how their physical and psychological problems affected them, which in turn led to disagreements and disempowerment. Finally, it was apparent that patients were lacking in information relating to their condition and treatment. This study identified that many aspects of patients' perceptions of their condition and treatments influenced their ability to tolerate compression bandages. Non-compliance is a multivariant concept in which both physical and psychological determinants play a key role. Nurses need to gain a clear understanding of patients' concurrent physical problems and perceptions of their health beliefs.