Antibiotics and antiseptics to help healing venous leg ulcers

O'Meara S, Al-Kurdi D, Ologun Y, Ovington LG

Published Online:

October 6, 2010

Venous leg ulcers are a type of wound that can take a long time to heal. These ulcers can become infected and this might cause further delay to healing. Two types of treatment are available to treat infection: systemic antibiotics (i.e. antibiotics taken by mouth or by injection) and topical preparations (i.e. applied directly to the wound). Whether systemic or topical preparations are used, patients will also usually have a wound dressing and bandage over the wound. This review was undertaken in order to find out whether using antibiotics and antiseptics works better than usual care for healing venous leg ulcers, and if so, to find out which antibiotic and antiseptic preparations are better than others. In terms of topical preparations, there is some evidence to support the use of cadexomer iodine. Further good quality research is required before definitive conclusions can be made about the effectiveness of systemic antibiotics and topical agents such as povidone iodine, peroxide-based preparations, ethacridine lactate, mupirocin and chlorhexidine in healing venous leg ulceration.

Abstract (click to read)

Background:

Venous leg ulcers are a type of chronic wound affecting up to 1% of adults in developed countries at some point during their lives. Many of these wounds are colonised by bacteria or show signs of clinical infection. The presence of infection may delay ulcer healing. There are two main strategies used to prevent and treat clinical infection in venous leg ulcers: systemic antibiotics and topical antibiotics or antiseptics.

Objectives:

The objective of the review is to determine the effects of systemic antibiotics, topical antibiotics and antiseptics on the healing of venous ulcers.

Search strategy:

For the update of this review we searched the Cochrane Wounds Group Specialised Register (searched 24/09/09); The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library 2009 Issue 3; Ovid MEDLINE - 1950 to September Week 3 2009; Ovid EMBASE - 1980 to 2009 Week 38; and EBSCO CINAHL - 1982 to September Week 3 2009. No language or publication date restrictions were applied.

Selection criteria:

Randomised controlled trials recruiting people with venous leg ulceration and evaluating at least one systemic antibiotic, topical antibiotic or topical antiseptic that reported an objective assessment of wound healing (e.g. time to complete healing, frequency of complete healing, change in ulcer surface area) were eligible for inclusion. Selection decisions were made by two authors working independently.

Data collection and analysis:

Information on the characteristics of participants, interventions and outcomes were recorded on a standardised data extraction form. In addition, aspects of trial methods were extracted, including randomisation, allocation concealment, blinding of participants and outcome assessors, incomplete outcome data and study group comparability at baseline. Data extraction and validity assessment were conducted by one author and checked by a second.

Main results:

Twenty five trials reporting 32 comparisons were identified. Five trials evaluated systemic antibiotics; the remainder evaluated topical preparations: cadexomer iodine (10 trials); povidone iodine (5 trials); peroxide-based preparations (3 trials); ethacridine lactate (1 trial); mupirocin (1 trial); and chlorhexidine (1 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. This trial, in common with the other evaluations of systemic antibiotics, was small and so the observed effect could have occurred by chance or been due to baseline imbalances in prognostic factors. For topical preparations, there is some evidence to suggest that cadexomer iodine generates higher healing rates than standard care. One study showed a statistically significant result in favour of cadexomer iodine when compared with standard care (not involving compression) in the frequency of complete healing at six weeks (RR 2.29, 95% CI 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. When cadexomer iodine was compared with standard care with all patients receiving compression, the pooled estimate from two trials for frequency of complete healing at 4 to 6 weeks indicated significantly higher healing rates for cadexomer iodine (RR 6.72, 95% CI 1.56 to 28.95). Surrogate healing outcomes such as change in ulcer surface area and daily or weekly healing rate showed favourable results for cadexomer iodine, peroxide-based preparations and ethacridine lactate in some studies. These surrogate outcomes may not be valid proxies for complete healing of the wound. Most of the trials 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.

Authors' conclusions:

At present, there is no evidence to support the routine use of systemic antibiotics to promote healing in venous leg ulcers. However, the lack of reliable evidence means that it is not possible to recommend the discontinuation of any of the agents reviewed. In terms of topical preparations, there is some evidence to support the use of cadexomer iodine. Further good quality research is required before definitive conclusions can be made about the effectiveness of systemic antibiotics and topical preparations such as povidone iodine, peroxide-based preparations, ethacridine lactate, mupirocin and chlorhexidine in healing venous leg ulceration. In light of the increasing problem of bacterial resistance to antibiotics, current prescribing guidelines recommend that antibacterial preparations should only be used in cases of clinical infection and not for bacterial colonisation.

This record should be cited as:

O'Meara S, Al-Kurdi D, Ologun Y, Ovington LG. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD003557. DOI: 10.1002/14651858.CD003557.pub3

Assessed as up to date:

November 4, 2009

Find the research

Get full text at The Cochrane Library

Primary Review Group:

Wounds Group

PEARLS - Practical Evidence About Real Life Situations (click to read)

Clinical question:

How effective are systemic antibiotics and antiseptics in healing venous ulcers?

Bottom line:

There is no evidence to support the routine use of systemic antibiotics to promote healing in venous leg ulcers. One study (involving daily dressings and bed rest but no compression) showed a statistically significant result in favour of cadexomer iodine (a topical agent with debriding and antibacterial effects) when compared with standard care in terms of frequency of complete healing at 6 weeks (NNT*5). However, only 60 patients were involved in the final analysis. *NNT = number needed to treat to benefit 1 individual.

Caveat:

The regimen used with cadexomer iodine was intensive and hospital based, and so these findings may not have been generalisable to most everyday clinical settings. Further good quality research is required before definitive conclusions can be made about the effectiveness of systemic antibiotics and topical agents, such as povidone iodine, peroxide-based preparations, ethacridine lactate and muciprocin. In the light of the increasing problems of bacterial resistance to antibiotics, current prescribing guidelines recommend antibacterial preparations should only be used in cases of defined infection and not for bacterial colonisation.

Context:

Venous leg ulcers affect up to 1% of adults in developed countries at some point during their life. Many of the wounds are colonised by bacteria or show signs of clinical infection, which may delay ulcer healing.

Cochrane Systematic Review:

O’ Meara S et al. Antibiotics and antiseptics for venous leg ulcers. Cochrane Reviews 2008, Issue 1. Article No. CD003557. DOI: 10.1002/14651858.CD003557.pub2. This review contains 22 trials involving 1543 participants.

Authored by:

Brian R McAvoy

Cochrane Primary Health Care Field

Health topics:

Heart & circulation > Ulcers: venous > Local wound care

Heart & circulation > Ulcers: venous > Systemic drug therapy

Wounds > Ulcers: venous > Local wound care

Wounds > Ulcers: venous > Systemic drug therapy

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Antibiotics and antiseptics to help healing venous leg ulcers

More like this

Copyright © 2011 - The Cochrane Collaboration