Here is the design of a clinical trial:

Official Title: Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)

Included conditions:
- Implant Complication
- Implant Infection
- Implant Site Infection
- Implant Capsular Contracture
- Implant Site Pocket Infection
- Implant Expulsion
- Antibiotic Side Effect

Study Armgroups:
- {'label': 'Irrigation of implants with sterile isotonic saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.', 'interventionNames': ['Other: Placebo']}
- {'label': 'Irrigation of implants with a triple antibiotic solution', 'type': 'EXPERIMENTAL', 'description': 'The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline', 'interventionNames': ['Drug: Gentamicin, Cefazolin and Vancomycin']}

Interventions:
- {'type': 'DRUG', 'name': 'Gentamicin, Cefazolin and Vancomycin', 'description': 'The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.', 'armGroupLabels': ['Irrigation of implants with a triple antibiotic solution'], 'otherNames': ['Hexamycin, Cefazolin "MIP" and Bactocin']}
- {'type': 'OTHER', 'name': 'Placebo', 'description': '500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.', 'armGroupLabels': ['Irrigation of implants with sterile isotonic saline'], 'otherNames': ['Natriumklorid Fresenius Kabi 9 mg-ml']}

Primary Outcomes:
- {'measure': 'All-cause explantation of the breast implant after the breast reconstruction surgery', 'description': 'All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation.', 'timeFrame': '180 days'}

Please estimate the sample size based on the assumption: 
The independent sample unit is 'breast'. The trial has an alpha of 0.05 and a power of 0.90. A drop-out rate of up to 10% is accounted for.
Sample size
        The trial is powered to find a 5% risk reduction in the primary outcome. Based on the literature, the assumed rate of implant loss in the control group is 10%.6 7 The independent sample unit is âbreastâ, because previous data do not suggest that implant loss is correlated between the two breasts of a patient.3 Therefore, the power of the trial is based on the number of breasts, so that the final number of included patients depends on the proportion of patients who undergo bilateral breast reconstruction. With an alpha of 0.05, the trial will have a power of 0.90 to detect an absolute risk reduction of 5% with 1158 breasts. To account for drop-out of up to 10%, we will include patients with a combined estimated number of 1274 breasts in the trial. We expect 27% of the patients to undergo bilateral breast reconstruction (based on unpublished data) and, therefore, 1003 patients will be included in the trial.