Surgical Infection
Conditions
Keywords
Antibiotic prophylaxis, surgical site infection, modified radical mastectomy, Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECefazolin
Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;
PROCEDURESterile water
Patients received sterile water only within 30 minutes prior to skin incision
Sponsors
University of the Philippines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women with histologically diagnosed breast cancer of age group 18-80 years old, ECOG 0-1, clinical stage I to IIIB, admitted to the surgery ward, who were scheduled for elective MRM.
Exclusion criteria
* Women with significant co-morbid factors (diabetes mellitus, severe malnutrition, corticosteroid therapy), those scheduled for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week prior to surgery, with known allergy to cephalosporins, and those with local infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (as defined by the Centers for Disease Control and Prevention) | Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days | 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: 1. purulent drainage (culture documentation not required) 2. organism isolated from fluid/tissue of incision site 3. at least one sign of inflammation (erythema, local warmth of wound, induration) 4. wound is deliberately opened by the surgeon 5. physician declares the wound infected |
Countries
Philippines
Outcome results
None listed