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Table 3 Summary of lessons learnt from the feasibility study

From: Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg

Issue

Problem

Solution implemented for the RCT

Definition of cellulitis

• Only 70% of those with cellulitis (as confirmed by a dermatologist) fulfilled the planned inclusion criteria to be used for the confirmation of cellulitis in the RCT.

• Inclusion criteria modified to be "Cellulitis as confirmed by a dermatologist". Individual clinical features will also be reported.

Recruitment

• Considerable difficulties in relying on UKDCTN members to recruit into the study.

• Measures to increase recruitment include: displaying information in relevant clinics; presenting at hospital clinical meetings; recruiting through A&E and acute medical wards; identifying patients through coding departments; and paying for greater administrative support at the recruiting centres.

Definition of recurrent cellulitis

• A definition of recurrent cellulitis for use in the trial was required.

• Recurrent cellulitis is defined as being "at least one previous episode of cellulitis of the leg within the preceding 3 years".

Alternative antibiotic for patients with penicillin allergy

• A surprisingly high proportion reported penicillin allergy (20%). Should an alternative be provided within the trial?

• No. The disadvantages (increased cost, more side effects and requirement for a double dummy) outweighed the recruitment advantage.

Treatment of existing risk factors

• During the trial, dermatologists will be increasingly involved in the care of patients with cellulitis. If this alters the normal clinical practice of the treating physician, this could reduce the recurrence rates seen in the control arm. For example, should the dermatologists recommend treatment of tinea pedis?

• Unethical not to highlight the need for treatment if risk factors are observed. The treating physician will be asked to follow usual practice and risk factors treated on their merit.

Impact of antibiotic resistance

• Concerns were expressed by patients, funding bodies and the ethics committee about the possible impact of long-term antibiotic therapy on microbial resistance.

• A review of the literature suggested that streptococcal infections have remained susceptible to penicillin for over 60 years, despite wide-spread use. There is no evidence to suggest that low-dose penicillin (which is currently used for other conditions, e.g.rheumatic fever) will lead to drug resistance. This fact is discussed at length in the supporting patient information leaflets.