Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers

Under Author Lazareth (2012) with his colleagues compared two-layer bandage system and four-layer bandage system, they found 187 patients were randomised to either the two-layer bandage (2lb, n=94) or four-layer bandage (4lb; n=93) system. The two groups were comparable, with regard to wound and patient characteristics, at baseline. By week 12, 44% of venous leg ulcers in the 2lb group and 39% in the 4lb group had healed (intention-to-treat [ITT] analysis). The per-protocol (PP) analysis showed that complete wound closure was obtained in 48% and 38% of the 2lb and 4lb groups, respectively. a non-inferiority margin within –10% is considered as demonstrating a 95% and 97.5% confidence interval (p=0.001). The AWAR was 6.6cm 2in the test and 4.9cm 2in the control group. The percentage of wounds with an RWAR ≥40% was 47% and 44% for the 2lb and 4lb systems, respectively. Pain between dressing changes was reported in 27% of the test and 40% of the control group, and the incidence of adverse events was 17% and 25%, respectively. The 2lb compression system was considered to be significantly easier to apply than the 4lb (p=0.038).

They conclude that The 2lb system was not seen to be any less efficient than a well-known 4lb system in the management of venous leg ulcers. Furthermore, the 2lb system was considered to be easier to apply, representing an alternative to the conventional treatment with 4lb currently available.