Antibiotic prophylaxis in patients undergoing primary or secondary breast reconstruction with implants, a randomized parallel two armed prospective clinical trial.

INTERVENTION: Trade Name: Kloxacillin 2g OR Klindamycin 600 mg Product Name: Kloxacillin or Klindamycin Product Code: 23584 or 25998 Pharmaceutical Form: Infusion INN or Proposed INN: CLOXACILLIN CAS Number: 61‐72‐3 Other descriptive name: CLINDAMYCIN CONDITION: The incidence of postoperative infections in patients with breast cancer or a history of breast cancer, after elective surgery with primary or secondary first‐time breast reconstruction with implants, given single dose or multiple doses of antibiotic prophylaxis. Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Investigate which intravenous antibiotic prophylaxis, single dose or multiple doses, that is the most effective concerning postoperative infections after primary and secondary first‐time breast reconstruction with implants. Primary end point(s): Postoperative infection:; Infection that leads to re‐surgery with removal of the breast implant Secondary Objective: Investigate if there is any difference in the incidence of adverse drug reactions between the single‐dose and the multiple‐dose antibiotic regimen Timepoint(s) of evaluation of this end point: Follow‐up on patients will be done at the following points in time:; 10 days (+‐3 days) after surgery; 1 months (+‐ 7 days) after surgery; 3 months (+‐ 7 days) after surgery; 6 months (+‐ 14 days) after surgery; 12 months (+‐ 14 days) after surgery SECONDARY OUTCOME: Secondary end point(s): Infection that requires per oral/parenteral antibiotics OR ; Timepoint(s) of evaluation of this end point: Follow‐up on patients will be done at the following points in time: ; 10 days (+‐3 days) after surgery ; 1 months (+‐ 7 days) after surgery ; 3 months (+‐ 7 days) after surgery ; 6 months (+‐ 14 days) after surgery ; 12 months (+‐ 14 days) after surgery INCLUSION CRITERIA: Women >18 years old Present diagnosis or a history of breast cancer Elective surgery with primary or secondary first‐time breast reconstruction with implants. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 780 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90