Thomas, K. and Crook, A. and Foster, K. and Mason, JM. and Chalmers, J. and Bourke, J. and Ferguson, A. and Levell, N. and Williams, H. (2012) 'Prophylactic antibiotics for the prevention of cellulitis (erysipelas) of the leg – results of the UK Dermatology Clinical Trials Network’s PATCH II trial.', British journal of dermatology., 166 (1). pp. 169-178.
Background: Cellulitis (erysipelas) of the leg is a common, painful infection of the skin and underlying tissue. Repeat episodes are frequent, cause significant morbidity and result in high health service costs. Objectives: To assess whether prophylactic antibiotics prescribed after an episode of cellulitis of the leg can prevent further episodes. Methods: Double-blind, RCT including patients recently treated for an episode of leg cellulitis. Recruitment took place in 20 hospitals. Randomisation was by computer generated code, and treatments allocated by post from a central pharmacy. Participants were enrolled for a maximum of 3 years and received their randomised treatment for the first 6 months of this period. Results: 123 participants were randomised (31% of target due to slow recruitment). The majority (79%) had suffered one episode of cellulitis on entry into the study. The primary outcome of time to recurrence of cellulitis included all randomised participants and was blinded to treatment allocation. The hazard ratio showed that treatment with penicillin reduced the risk of recurrence by 47% (HR 0.53, 95% CI 0.26 to 1.07, p = 0.08). In the penicillin V group 12/60 (20%) had a repeat episode compared with 21/63 (33%) in the placebo group. This equates to a number needed to treat (NNT) of eight participants in order to prevent one repeat episode of cellulitis (95% CI NNT(harm) 48 to ∞ to NNT(benefit) 3. We found no difference between the two groups in the number of participants with oedema, ulceration or related adverse events. Conclusions: Although this trial was limited by slow recruitment, and the result failed to achieve statistical significance, it provides the best evidence available to date for the prevention of recurrence of this debilitating condition.
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|Publisher Web site:||http://dx.doi.org/10.1111/j.1365-2133.2011.10586.x|
|Record Created:||24 Nov 2011 16:05|
|Last Modified:||02 Feb 2012 14:20|
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