Cellulitis/Erysipelas of the Leg Clinical Trial
Official title:
Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)
To assess whether a period of prophylactic penicillin after an episode of cellulitis of the leg reduces the risk of repeat episodes. Participants are randomised to receive 12 months of prophylaxis (penicillin VK 250mg b.d. or placebo). The PATCH I study will recruit only patients with recurrent disease.
Cellulitis of the leg is an common, acute, painful and potentially serious infection of the
skin and subcutaneous tissue. It currently accounts for 2-3% of UK hospital admissions. The
average length of in-patient stay is 9 days (Hospital Episode Statistics, Department of
Health (UK), 2002-2003) and 25-50% of treated patients suffer further episodes and other
morbidity, such as oedema and ulceration.
Cellulitis of the lower leg is usually due to streptococcal infection that has entered into
the body via a relatively subtle portal, such as toeweb fissures. Penicillin is the most
useful of the commonly used oral antibiotics against streptococci, although other agents such
as flucloxacillin are often used if staphylococcal infection is a clinical possibility.
There are numerous risk factors for cellulitis of the lower leg and recurrent disease is one
the biggest problems.
Existing evidence for the use of prophylactic antibiotics to prevent further episodes is very
limited. Two small randomised controlled trials (RCTs) hint at possible benefit, but these
studies are very small (16 and 40 participants respectively). Despite this, many physicians
routinely use prophylactic antibiotics for recurrent cellulitis, although opinions on the
value of such practice is firmly divided.
This study will recruit over a 12-24 month period participants who have completed the therapy
for the current episode of cellulitis. Participants will be followed up for up to 24 months
with telephone calls at 10 days, 3 months, 6 months, 9 months and 12 months and then every 6
months after completing the intervention. A diary will also be provided as an "aid memoir" to
phone calls and to note missed tablets and recurrence of cellulitis.
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