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
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
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)
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