Active Ingredient: Ciprofloxacin
Accepted Aug 11. This article has been cited by other articles in PMC. Summary 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, randomized controlled trial including patients recently treated for an episode of leg cellulitis.
Recruitment took place in 20 hospitals.
Randomization 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 randomized treatment for the first 6 months of this period.
The primary outcome of time to recurrence of cellulitis included all randomized participants and was blinded to treatment allocation. 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.
Evidence for the use of prophylactic antibiotics to prevent further episodes is very limited.
Three small randomized controlled trials RCTs hint at possible benefit with 16, 40 and 58 participants, respectively. Dermatology Clinical Trials Network. PATCH I has recruited to target and is due to report in, and will assess the impact of 12 months of prophylactic phenoxymethylpenicillin penicillin V in patients with recurrent cellulitis at least two previous episodes.
The PATCH II trial, reported here, assesses whether 6 months of prophylaxis with penicillin V is effective in reducing repeat episodes of cellulitis of the leg in patients who have had one or more episodes.
A summary of the protocol has also been published.
As this was a prevention study, normal care was considered to be no treatment and so a placebo control group was an appropriate comparator. Participants were allocated on a 1: 1 basis, and were followed up by telephone from the coordinating centre for a maximum of 36 months, depending on when they were enrolled.
Changes to the trial design after registration of the protocol, but prior to start of recruitment, included i the number of repeat episodes of cellulitis was added as an additional secondary outcome measure, as this had been omitted in error; ii exclusion criteria were amended to include conditions which prohibit the use of penicillin V, and having taken prophylaxis for the prevention of cellulitis within 6 months of the index episode.
Patients were identified either at presentation in secondary care through emergency departments, medical admissions units, medical wards and outpatient clinics, or retrospectively via discharge coding or poster adverts.
Other electrolytes and creatinine were normal. Oral supplementation with potassium chloride, calcium carbonate, and magnesium sulfate was instituted. Furosemide was discontinued.