The University of Nottingham

In the largest randomised trial of its kind, dermatologists from the UK have discovered that taking low dose penicillin twice a day for a year can reduce the number of repeat episodes of leg cellulitis. But this protection is lost once the antibiotics are stopped so longer-term antibiotics may be required.

The results of the trial, led by Hywel Williams, Professor of Dermato-Epidemiology and Director of the Centre of Evidence Based Dermatology at The University of Nottingham, will improve the lives of many thousands of patients who suffer from this painful condition, and could potentially reduce costs to health care providers by reducing hospital admissions.

The results of the PATCH I trial, funded by Action Medical Research (AMR), are published Wednesday 1 May 2013 in the New England Journal of Medicine.

Cellulitis of the leg is a common, painful and potentially serious bacterial infection of the skin. It can spread rapidly and often leads to long term damage. Cellulitis is one of the most common reasons for emergency admissions to hospital and up to half of patients have repeat attacks or other difficulties such as swelling and ulceration.

PATCH 1 was conceived by the late Professor Neil Cox of Carlisle and coordinated by the UK Dermatology Clinical Trials Network based in the Centre of Evidence Based Dermatology at The University of Nottingham with support from the Medical Research Council Clinical Trials Unit.

The trial, involving 274 patients from 28 hospitals across the UK and Eire, was designed to see if low dose penicillin (250 mg) taken twice a day for 12 months could prevent further attacks in patients who suffer from repeat episodes of leg cellulitis. Patients who had experienced at least two episodes of leg cellulitis in the last three years were included in this trial. They remained in the trial for up to three years to see whether or not the penicillin was effective only whilst it was being taken, or whether there were longer term benefits after the antibiotics had been stopped.

The PATCH I trial found that patients in the penicillin group were less likely to have another attack of cellulitis compared with the placebo group (22 per cent compared with 37 per cent). However, this protection was gradually lost after patients stopped taking the medication at 12 months. In fact, by three years, around half of all patients in both groups had suffered at least one further episode.

Professor Williams said: “Cellulitis of the leg is common. It causes a lot of pain and distress to patients, and results in time off work or other daily activities. By demonstrating that a simple, low cost and safe intervention such as low-dose penicillin taken for 12 months can reduce the number of repeat episodes, we could improve their lives significantly and reduce the number of hospital admissions which result from this long term, painful and disfiguring condition.

By improving the evidence base on this topic, patients and doctors can make informed choices about the management and prevention of leg cellulitis.”

The research team acknowledge the support from Action Medical Research, the Nottingham Clinical Trials Unit and the National Institute for Health Research Comprehensive Local Research Networks.

Four case studies are available. These patients are happy to talk about their experience of living with cellulitis and taking part in the trial. They are from Leicester, Mansfield and Nottingham, and Barton-under-Needwood in Staffordshire are available on request.

The following dermatologists are available for interviews:

Professor Hywel Williams, Hywel.williams@nottingham.ac.uk, +44 (0)115 823 1048.

Dr Shernaz Walton, Consultant Dermatologist at the Hull Royal Infirmary, Shernaz.Walton@hey.nhs.uk, +44 (0)1482 608766

Dr Graham Johnston, Consultant Dermatologist at the University Hospitals of Leicester NHS Trust Leicester, graham.johnston@uhl-tr.nhs.uk, +44 (0)116 2587562

(Email only) Dr Nick Levell, Consultant Dermatologist at the Norfolk and Norwich University Hospital, nick.levell@nnuh.nhs.uk