Individual research recommendation details

Recommendation ID

NG152/1

Question

What is the clinical effectiveness of topical treatments (antibiotics and antiseptics) compared with oral antibiotics for the treatment of infected leg ulcer?

Any explanatory notes
(if applicable)

Why the committee made the recommendations
Recommendations 1.1.1 to 1.1.5

The committee agreed that health professionals should be aware that there are many causes of leg ulcers and that, although most leg ulcers are colonised by bacteria, few are infected. They discussed that it is important to ensure that underlying conditions, such as venous insufficiency and oedema, are managed appropriately.

The committee discussed that antibiotics should only be offered for adults with a leg ulcer when there are symptoms or signs of infection. They agreed that there was no difference in outcomes between treatment with antibiotics and standard care in people with uninfected leg ulcers (although this was from a small, very low-quality study with no details reported on dosage or route of administration).

Evidence showed no difference in complete healing of the leg ulcer with antibiotics compared with standard care or placebo. However, in all but 1 study, the ulcer was either uninfected or the infection status was unclear. No study stated that children and young people (under 18 years) were included. The committee agreed that this age group are very unlikely to develop a leg ulcer and if they do the cause is likely to be from a condition that needs specialist management. Therefore, it was not appropriate to extrapolate evidence for adults to children and young people and so the committee made recommendations for adults only.

The committee agreed that antibiotics should be offered to all adults with a leg ulcer if there are symptoms or signs of an infection, because untreated infection causes delays in ulcer healing, affecting quality of life and sometimes resulting in hospital admission. The committee discussed that studies did not use consistent criteria for identifying infection in ulcers, and some signs of infection (such as localised redness, discharge and unpleasant smell) could be present in all leg ulcers, regardless of infection status, especially once compression is removed. Therefore, they agreed that the symptoms or signs to use to determine if the ulcer is infected may include redness or swelling spreading beyond the ulcer, localised warmth, increased pain or fever. The committee noted that healthcare professionals should be aware that redness, 1 of the signs of infection, may be less visible on darker skin tones.

Based on experience, the committee agreed that antibiotic choice will depend on the severity of symptoms or signs of infection (for example, how rapidly the infection is progressing or expanding), the person's risk of complications (possibly because of comorbidities, such as diabetes or immunosuppression) and any previous antibiotic use (which may have led to antimicrobial resistance).

In line with the NICE guideline on antimicrobial stewardship: systems and processes for effective antimicrobial medicine use and Public Health England's antimicrobial stewardship: start smart – then focus toolkit, oral antibiotics should be given first if the person can take them, and if the severity of their infection does not require intravenous antibiotics. The use of intravenous antibiotics should be reviewed by 48 hours (taking into account the person's response to treatment and any microbiological results) and switched to oral treatment where possible.

The committee discussed and agreed that samples for microbiological testing should not routinely be taken from a leg ulcer at initial presentation, whether it is thought to be infected or not. Most leg ulcers are colonised by bacteria, and bacterial growth from a sample is likely regardless of infection status. Universal sampling could lead to inappropriate antibiotic prescribing. If the leg ulcer is clinically infected, the most likely causative organism is Staphylococcus aureus, which would be covered by empirical treatment with flucloxacillin.

Topical antiseptics
Evidence comparing antibiotics with povidone-iodine (an antiseptic) for leg ulcer infection was limited by small sample size. Most of the evidence was in adults with unclear infection status or uninfected leg ulcer.

There was some evidence of effect for cadexomer‑iodine and silver dressings in people with infected leg ulcer (compared with standard care and non-adherent foam dressing respectively). But there were severe limitations, including an unclear definition of 'infection' (1 being reliant on laboratory growth and the other stating that inflammation was the only symptom required). For the comparison of silver dressings and foam dressings, the only sign of infection required was inflammation, there were very wide confidence intervals, and both study arms had the option to use antibiotics (and the number of people taking systemic antibiotics was not reported). Silver dressings can be expensive and could have considerable resource impact. Therefore, because of the inadequate definition of infection, the confounding issue of antibiotic use, the uncertainty of the effect estimate and the potential cost, the committee agreed not to recommend silver dressings.

The committee were also concerned about the adverse effects with cadexomer‑iodine. These were mainly local skin irritation, rash and pain, all of which can make leg ulcers worse. No adverse effects were reported for silver dressings, but this may have been because of the small sample size. The committee were also aware of issues with the availability of iodine-based preparations, particularly in community settings.

In clinical practice, topical antiseptics are used for leg ulcers, often to manage minor, localised infections. However, the committee agreed that they could not make any recommendations on the use topical antiseptics for treating infected leg ulcers because of the limitations of the evidence and the unclear benefit. The inability to differentiate between a more localised or widespread infection both in the evidence and in clinical practice makes it difficult to define any place in therapy for topical antiseptics. The committee decided that it was appropriate to make a research recommendation on the effectiveness of topical treatments (antiseptics and antibiotics) compared with oral antibiotics.

For more details, see the summary of the evidence on antibiotics and topical antiseptics.

Source guidance details

Comes from guidance

Leg ulcer infection: antimicrobial prescribing

Number

NG152

Date issued

February 2020

Other details