Randomized clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers (VenUS I)

Abstract

Abstract Background A randomized clinical trial was undertaken to determine the relative effectiveness of four-layer and short-stretch bandaging for venous ulceration. Methods A total of 387 adults with a venous ulcer, who were receiving leg ulcer treatment either in primary care or as a hospital outpatient, were recruited to this parallel-group open study and randomized to either four-layer or short-stretch bandages. Follow-up continued until the patient's reference leg was ulcer free or for a minimum of 12 months. The primary endpoint was time to complete healing of all ulcers on the reference leg. Secondary outcomes included proportion of ulcers healed, health-related quality of life, withdrawals and adverse events. Analysis was by intention to treat. Results Unadjusted analysis identified no statistically significant difference in median time to healing: 92 days for four-layer and 126 days for short-stretch bandages. However, when prognostic factors were included in a Cox proportional hazards regression model, ulcers treated with the short-stretch bandage had a lower probability of healing than those treated with the four-layer bandage: hazard ratio 0·72 (95 per cent confidence interval 0·57 to 0·91). More adverse events and withdrawals were reported with the short-stretch bandage. Conclusion Venous leg ulcers treated using a four-layer bandage healed more quickly than those treated with a short-stretch bandage.