PATCH I & PATCH II
Randomised controlled trials to investigate whether prophylactic antibiotics can prevent further episodes of cellulitis (erysipelas) of the leg
This protocol describes two closely related trials looking at the impact of 6 and 12 months of prophylaxis on subsequent episodes of cellulitis of the leg.
Details of the disease
Cellulitis of the leg is a common, painful and serious infection of the skin and the tissues just below the skin surface. It appears as a red area of skin that feels hot and tender, and it may spread rapidly. Around 2-3% of all people admitted to hospital have cellulitis and they usually have to stay in hospital for around nine days. Up to half of patients treated suffer from repeat attacks, or other difficulties such as swelling of the leg and ulceration.
The proposed research
These two studies will tell us if low dose penicillin given after an attack of cellulitis can prevent further attacks and complications, such as swelling and ulceration.
It is a randomised controlled trial in which people with cellulitis are given either penicillin or a placebo tablet for 12 months for PATCH I or six months for PATCH II. We will continue to monitor these people for two to three years, to see if the penicillin group have fewer attacks of cellulitis than the placebo group. If it does, then it means that this simple treatment can make a big improvement to the quality of life of the thousands of people in the UK who suffer from repeat attacks of cellulitis. Preventing further attacks will also save money for the NHS by reducing hospital admissions.
This study is taking place from October 2005 to December 2010.
Recruitment
Trials co-ordinated through the Network need to be conducted to EU Clinical Trials Directive regulations. Therefore they will require ethics, research and development (R & D) and MHRA approval.
Material for these submissions will be prepared centrally at the co-ordinating centre. However, principal investigators at each of the recruiting centres will be required to complete site-specific information and to submit the forms to their local ethics and R & D departments.
Study information and documents required for obtaining regulatory approval and conducting the study can be found by clicking on the PATCH logo below.
Please note you will need your membership number and password to access these documents.
Funding
PATCH I has been kindly funded by Action Medical Research.
PATCH II has been kindly funded by The BUPA Foundation.
The full protocol is available in the members' only section.
For further information about this study or about becoming a recruiting centre, please contact Katharine Foster. Please note that PATCH II is now closed to recruitment.
