Goals and Objectives: To evaluate bandage slippage, Health Related Quality of Life (HRQoL) and patient preference in venous leg ulcer patients treated with a two-layer* and a four-layer^† compression bandage system.

Methods: This was an eight-week, ten-center, prospective, randomized, crossover, open-label, clinical trial. Participants (n=81) were randomized to one of the two compression systems. Treatment crossover occurred at week 4. All ulcers were covered with the same primary dressing,^‡ and compression bandages were applied over the dressing. All other ulcer treatments were per standard procedure at each location. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing/wound area reduction, HRQoL (Cardiff Wound Impact Schedule), and patient preference (questionnaire).

Results: Mean slippage estimated from a mixed ANOVA model (701 measurements) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (p<0.0001). There were no significant differences in percent of wounds that healed (Fisher's Exact Test, p=0.47) or in wound area reduction (Wilcoxon Rank-Sum Test, p=0.87). Changes during Period 1 in HRQoL Physical Symptoms and Daily Living Scores were significantly higher with the two-layer system (pooled 2-sample t-test, p=0.046). Patients had a strong preference for the two-layer system (72%) vs. the four-layer system (22%), with 6% having no preference. Patient preference was similar regardless of randomization order (p>0.99).

Discussion and Conclusions: This study reveals that there is significantly less bandage slippage with the two-layer system compared to the four-layer system. While less bandage slippage in this study did not appear to have an impact on wound healing, it may have influenced patient preference in favor of the two-layer system and impacted patient HRQoL.

* Coban™ 2-Layer Compression System

^† Profore™ multi-layer compression bandage system

^‡ Tegaderm™ Foam Dressing