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

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 All withdrawn patients had a negative outcome score over the whole study duration.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.