A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)
Mastectomy wounds were evaluated for the presence of SSI as defined by the Center for Disease Control and Prevention meeting the following criteria: infection that occurred within 30 days after the operative procedure and at least one of the following: purulent drainage (culture documentation not required) organism isolated from fluid/tissue of incision site at least one sign of inflammation (erythema, local warmth of wound, induration) wound is deliberately opened by the surgeon physician declares the wound infected
Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days
Nelson C Cabaluna, Doctor of Medicine
University of the Philippines Manila
Philippines: UP Manila National Institutes of Health - Research Management Committee