Here is the design of a clinical trial:

Official Title: Open-label, Multicentre, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Oxygen-ozone Therapy Plus Oral Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices

Included conditions:
- Infection

Study Armgroups:
- {'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'Oxygen-ozone therapy plus antibiotic therapy', 'interventionNames': ['Procedure: Oxygen-ozone therapy']}
- {'label': 'Arm B', 'type': 'OTHER', 'description': 'Antibiotic therapy', 'interventionNames': ['Procedure: Oxygen-ozone therapy']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Oxygen-ozone therapy', 'description': 'Oxygen-ozone therapy (group a) will be performed by:\n\ni) Self-haemoinfusion of 200 cc. with concentrations of 40-50 μg/ml, to be performed two/three times a week, for a time of 6 weeks (for a maximum of 15 sessions); ii) Subcutaneous injections in the perilesional site at the dose of 5 cc. with concentrations of 4 μg,/ml, Cleanse wounds with 100 cc of 5-10 ug ozone gas', 'armGroupLabels': ['Arm A', 'Arm B']}

Primary Outcomes:
- {'measure': 'Clinical success at Day 14', 'description': 'Resolution/improvement of signs and symptoms of infection of the wound in the target lesion (i.e. a score ≤ 1 for a maximum of two signs/symptoms) from baseline to Day 14. The following symptoms will be evaluated by patients on a 0-4 point Likert scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom; 4 = very severe symptom): pain, burning, redness and malodour.\n\nThe following signs will be evaluated by investigators on a 0-4 point Likert scale (0 = no sign; 1 = mild sign; 2 = moderate sign; 3 = severe sign; 4 = very severe sign): erythema, local warmth, swelling, purulent secretion.', 'timeFrame': '2 week'}

Please estimate the sample size based on the assumption: 
Power of 80%, significance level of 0.05 (two-sided), dropout rate of 10%, and the statistical test used is the two-sided Z-test with pooled variance.
Sample size
        The study will include a total of 186 evaluable patients, 93 in each treatment group. Considering a dropout rate of 10%, up to 104 patients in each group will be enrolled. Being a superiority design, the sample size is discussed for the primary efficacy endpoint, defined as the proportion of patients with clinical success on Day 14.
        For the calculations, it has been assumed that:
        
          
            Ffity per cent of patients receiving antibiotic therapy alone and 70% of patients receiving antibiotic oxygen-ozone therapy will experience clinical success, with a difference between group proportions of 20%.
          
          
            With a power of 80% and a significance level of 0.05 (two-sided), 93 patients in each treatment group are required.
          
          
            The statistical test used is the two-sided Z-test with pooled variance.