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| Randomised controlled trial to investigate whether prophylactic antibiotics can prevent further episodes of cellulitis (erysipelas) of the leg (PATCH II) |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN03813200 |
| Date ISRCTN assigned | 06/12/2007 |
| Local reference number(s) | 26083 |
| Public title | Randomised controlled trial to investigate whether prophylactic antibiotics can prevent further episodes of cellulitis (erysipelas) of the leg (PATCH II) |
| Scientific title | |
| Acronym | PATCH II - Prophylactic Antibiotics for the Treatment of Cellulitis at Home II |
| Disease/condition/study domain | Cellulitis of the leg |
| Study hypothesis | To assess whether a period of six months of prophylactic penicillin after an episode of cellulitis of the leg reduces the risk of repeat episodes. |
| Design/methodology | Multi-centre double-blind randomised controlled trial. |
| Research ethics review | Approved by the Nottingham Research Ethics Committee (2) on the 27th March 2006. |
| Countries of trial | United Kingdom and Ireland. |
| Participants - inclusion criteria | Cellulitis of the leg |
| Participants - 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 |
| Patient information material | For both PATCH I and PATCH II: Full version: http://ctsu.nottingham.ac.uk/ts0601/docs/Participant%20Information%20Sheet%20v1%203.doc Short version: http://ctsu.nottingham.ac.uk/ts0601/docs/Short%20Participant%20information%20sheet%20v1%200.doc |
| Anticipated start date | 01/01/2007 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Ongoing |
| Target number of participants | 400 |
| Interventions | Penicillin VK 250 mg orally twice a day (b.d.) or placebo (b.d.) for 6 months. |
| Primary outcome measure(s) | 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 outcome measure(s) | 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. |
| Trial website | http://www.patchtrial.co.uk |
| Sources of funding | The BUPA Foundation (UK) |
| Sponsor name | University of Nottingham (UK) |
| Sponsor details | Research Innovation Services King's Meadow Campus University of Nottingham Lenton lane Nottingham United Kingdom NG7 2NR |
| Contact name | Prof Hywel Williams |
| Contact details | Department of Dermatology South Block Queens Medical Centre Nottingham United Kingdom NG7 2UH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN03813200 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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