Cellulitis of the leg Skin and Connective Tissue Diseases Cellulitis
Conditions
Interventions
Penicillin VK 250 mg orally twice a day (b.d.) or placebo (b.d.) for 6 months.
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cellulitis of the leg
Exclusion criteria
Exclusion criteria: 1. Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention of cellulitis within 6 months prior to index episode 2. A time lapse of longer than 12 weeks since the start of treatment for the index episode to the date of potential randomisation into the trial 3. Known allergy to penicillin 4. Preceding leg ulceration, surgery or penetrating trauma (NB: this does not exclude patients with toeweb maceration/tinea pedis or other minor/blunt wounds) 5. Treating physician or principal investigator unwilling to randomise patient 6. No access to a telephone 7. Aged less than 16 years 8. Unable to give informed consent 9. Already taking part in a research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to next episode of cellulitis. Follow-up duration for primary endpoint: up to 3 years depending on date of recruitment into the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with repeat episodes of cellulitis in the active treatment arm compared with the placebo treatment arm at the end of the treatment phase, and at the end of the non-intervention follow-up phase 2. Proportion of participants with oedema and/or ulceration in the active treatment arm compared with the placebo treatment arm at the end of the treatment phase, and at the end of the non-intervention follow-up phase 3. Number of nights in hospital for the treatment of repeat episodes of cellulitis. Duration of follow-up: up to 3 years depending on date of recruitment into the trial. 4. Number of adverse drug reactions reported in each treatment arm. Duration of follow-up: up to 3 years depending on date of recruitment into the trial. 5. Cost-effectiveness, including GP consultations, prescriptions for antibiotics and days in hospital 6. Predictors of response multiple regression model to explore the impact of known risk factors in predicting the efficacy of prophylaxis 7. Impact of cellulitis on health-related quality of life, assessed using the EuroQol (EQ-5D) and also a measure specific to dermatology (the Dermatology Life Quality Index [DLQI]). These will be measured at baseline (i.e. during the index episode of cellulitis) and at 10 days. The same measures will also be taken during any repeat episodes of cellulitis. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed