Trial stopped early for efficacy in participants with chronic edema of the leg and recurrent cellulitis
FRIDAY, Aug. 14, 2020 (HealthDay News) — For patients with chronic edema of the leg and cellulitis, compression therapy results in a lower incidence of cellulitis recurrence, according to a study published in the Aug. 13 issue of the New England Journal of Medicine.
Elizabeth Webb, M.P.H., from Calvary Public Hospital Bruce in Australia, and colleagues enrolled 84 patients with chronic edema of the leg and recurrent cellulitis in a 1:1 ratio to receive either leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group; 41 and 43 participants, respectively). Participants were followed every six months for up to three years or until 45 episodes of cellulitis had occurred.
The researchers found that 15 and 40 percent of participants in the compression and control groups, respectively, had had an episode of cellulitis at the planned interim analysis when 23 episodes of cellulitis had occurred (hazard ratio, 0.23 [95 percent confidence interval (CI), 0.09 to 0.59; P = 0.002]; relative risk [post-hoc analysis], 0.37 [95 percent CI, 0.16 to 0.84; P = 0.02]), and the trial was stopped for efficacy. Overall, 7 and 14 percent of participants in the compression and control groups, respectively, were hospitalized for cellulitis (hazard ratio, 0.38; 95 percent CI, 0.09 to 1.59). The groups did not differ in most quality-of-life outcomes.
“Larger and longer trials are necessary in order to determine the effect of compression therapy on the recurrence of cellulitis, especially in settings without access to specialized lymphedema services,” the authors write.
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