Surgical Infection Clinical Trial
Official title:
A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
This is a randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
A randomized, double blinded, placebo-controlled trial on the routine use of preoperative
antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of
preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in
patients undergoing modified radical mastectomy (MRM) for breast care.
Women with breast cancer who will undergo elective MRM were recruited for the study.
Excluded were patients with significant co-morbid factors, for simultaneous breast
reconstruction or bilateral oophorectomy, with intake of antibiotics within one week, with
known allergy to cephalosporins, and those with local infection. Patients were randomized to
receive either transvenous cefazolin 1 gram or sterile water only within 30 minutes prior to
skin incision. Standard skin preparation and operative technique for MRM were carried out.
Wounds were assessed for the presence of SSI and other complications weekly for 30 days.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention