Valtonen 1989.
Methods | Randomised controlled trial conducted in Finland | |
Participants | 27 participants with Pseudomonas aeruginosa or other Gram‐negative rod colonised chronic leg ulcers of ≥ 2 months' duration were recruited. Patients with diabetes were eligible for inclusion. Those with ulcer flora resistant to ciprofloxacin were excluded:
Group 1: 8 participants
Group 2: 18 participants Numbers (%) of participants with venous/arterial insufficiency: Group 1: 6/8 (75%); 8/8 (100%) Group 2: 16/18 (89%); 13/18 (72%) Mean ± SD sum of maximum length plus width of ulcer (cm) at baseline: Group 1: 16.9 ± 11.4; Group 2: 16.7 ± 8.2 Range for baseline ulcer duration, months: Group 1: 29 to 35; Group 2: 60 to 71 Proportions of participants with isolation of Pseudomonas aeruginosa at baseline: Group 1: 63%; Group 2: 61% Unclear whether wounds had signs and symptoms of clinical infection at baseline or whether just colonised |
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Interventions | 1. Standard care consisting of: daily ulcer cleansing with warm water and disinfectants (chlorhexidine or potassium permanganate); mechanical or enzymatic debridement; coverage with dextranomer paste or hydrocolloid (DuoDerm) dressing. Topical antibiotic creams were not used 2. Oral ciprofloxacin 750 mg twice daily for 3 months in addition to standard care as above. Some participants received a lower dose as the study progressed (250 or 500 mg twice daily) to achieve a maximum serum level of 2 to 4 mg/L. All participants were treated as inpatients or outpatients according to clinical status; additional systemic antibiotics based on clinical features of infection, and the resistance pattern of the bacteria isolated. Use of compression not mentioned |
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Outcomes | Primary outcomes: Numbers (%) of participants with complete healing at 3 months: 1. 0/8 (0) 2. 3/18 (17) Numbers (%) of participants with clinical improvement (defined as those with complete healing plus those with reduction of at least 10% of sum of maximum length and width of ulcer) at 3 months: 1. 1/8 (13) 2. 12/18 (67) Secondary outcomes: Numbers of participants with adverse events: Group 1: (0) Group 2: mild, transient nausea that did not result in discontinuation of treatment (3) Numbers (%) of participants who needed extra antimicrobial treatment during the trial: 1. 6/8 (75) 2. 3/18 (17) Numbers (%) of participants with bacterial eradication or no bacteriological growth during trial: 1. 1/8 (13) 2. 6/18 (33) Numbers (%) of participants with eradication of original strain during trial: 1. 2/8 (25) 2. 15/18 (83) Numbers (%) of participants with ciprofloxacin‐resistant strain in ulcer during trial: 1. 0/8 (0) 2. 12/18 (67) |
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Notes | One participant excluded from analysis because of malignant tumour in leg ulcer (group allocation not stated) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomised to two treatment groups." It was not stated how the sequence was generated |
Allocation concealment (selection bias) | Unclear risk | No information was provided |
Blinding (performance bias and detection bias) Participant blinded to the intervention | Unclear risk | "We have studied, using an open, comparative study design, the efficacy of..." |
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | "We have studied, using an open, comparative study design, the efficacy of..." |
Incomplete outcome data (attrition bias) Drop out rate described | Low risk | "Altogether 27 patients enrolled..." One was excluded from analysis |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Low risk | One participant was excluded because of malignancy in ulcer |
Incomplete outcome data (attrition bias) ITT analysis | Low risk | Participants were analysed in the groups into which they were enrolled at the beginning of the study |
Baseline factors comparable | High risk | Longer baseline ulcer duration in ciprofloxacin group |