This is the Scientific Surgery Archive, which contains all randomized clinical trials in surgery that have been identified by searching the top 50 English language medical journal issues since January 1998. Compiled by Jonothan J. Earnshaw, former Editor-in-Chief, BJS
Randomized clinical trial of four‐layer and short‐stretch compression bandages for venous leg ulcers (VenUS I). BJS 2004; 91: 1292-1299.
Published: 20th September 2004
Authors: E. A. Nelson, C. P. Iglesias, N. Cullum, D. J. Torgerson
Background
A randomized clinical trial was undertaken to determine the relative effectiveness of four‐layer and short‐stretch bandaging for venous ulceration.
Method
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. Copyright © 2004 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
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