NPC Archive Item: What evidence is there for using antibiotics and antiseptics in the treatment of infected venous leg ulcers?

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O’Meara S, Al-Kurdi D, Ovington LG. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD003557. DOI: 10.1002/14651858.CD003557.pub2.

What is the background to this?
Infection of venous leg ulcers may delay wound healing, and for this reason, systemic antibiotics are frequently given. Topical antiseptics and antibiotics may also be used. A Cochrane review has examined the evidence supporting the use of antibiotics and antiseptics in venous leg ulcers.

What does this study claim?
The authors found that there was no existing evidence to support the routine use of systemic antibiotics to promote healing in venous leg ulcers. However, the lack of reliable evidence meant that they were also not able to recommend the discontinuation of any of the agents reviewed. In terms of topical preparations, they only identified evidence to support the use of cadexomer iodine.

So what?
Most of the trials reviewed were small and many had methodological problems such as poor baseline comparability between groups, failure to use (or report) true randomisation, adequate allocation concealment, blinded outcome assessment and analysis by intention-to-treat. Thus, drawing any definitive conclusions about the efficacy of systemic or topical agents was impossible. As pointed out in a previous blog (October 2007), there is a clear need for better quality research in wound care.

Until there is better quality evidence to support the use of any particular topical or systemic treatment for the infected leg ulcers, and in the absence of NICE guidance, prescribers should consider following the recently revised CKS guidance for the management of venous leg ulcers that are suspected of being infected. Included in the guidance is the recommendation that a wound swab is taken for all suspected infected venous leg ulcers before prescribing an antibiotic, and prescribing flucloxacillin or erythromycin for 7 days, whilst awaiting swab results. Clarithromycin is an alternative for people who are unable to tolerate erythromycin. Topical antibiotics, which are often associated with sensitivity reactions, are not recommended. The guidance also has recommendations for subsequent follow up, and what to do if the ulcer is not responding to treatment.

Study details:
The reviewers identified 22 studies of different antibiotics and antiseptics, including systemic antibiotics (five trials). The remainder were topical preparations: cadexomer iodine (10 trials); povidone iodine (two trials); peroxide-based preparations (3 trials); ethacridine lactate (one trial); and mupirocin (one trial). For the systemic antibiotics, the only comparison where a statistically significant between-group difference was detected was that in favour of the antihelminthic levamisole when compared with placebo. However, as with all other trials of systemic antibiotics, it was small and the observed effect could have occurred by chance. One study showed a statistically significant result in favour of cadexomer iodine when compared with standard care (not involving compression) in terms of frequency of complete healing at six weeks (relative rate 2.29, 95% confidence interval 1.10 to 4.74). The intervention regimen used was intensive, involving daily dressing changes, and so these findings may not be generalisable to most everyday clinical settings.

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