Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers

Abstract

Background: Compression therapy is not common for venous leg ulcer patients in Hong Kong.

Methods: This randomized controlled trial compared the clinical effectiveness of compression bandaging using four-layer bandaging (4LB) or short-stretch bandaging (SSB) and usual care (moist wound healing dressing without compression). The 24-week study looked at venous leg ulcer patients aged >60 years in a community setting. The primary parameter was time to ulcer healing. Secondary parameters were ulcer area and pain reduction comparing week 0 (start) vs week 24 (end), measuring results per group and between groups. Intention-to-treat analysis involved descriptive statistics, survival analysis, and repeated measures analysis of variance. The log-rank test was used for univariable analysis. All withdrawn patients had a negative outcome score over the whole study duration.

Results: Of 321 patients who received randomized treatment, 45 (14%) did not complete the 24-week study period. At 24 weeks, Kaplan-Meier analysis on healing time was statistically significant (P < .001) in favor of the compression groups. The mean (SD) healing time in the SSB group (9.9 [0.77]) was shorter than that of the 4LB group (10.4 [0.80]) and the usual care group (18.3 [0.86]). Pain reduction was significant (P < .001) for the compression-treated groups only.

Conclusions: Compression bandaging was more effective than usual care without compression. Both compression systems were safe and feasible for venous ulcer patients in a community setting in Hong Kong.