Breast Neoplasms Clinical Trial
Official title:
Antibiotic Prophylaxis in Oncological Surgery of Breast: Randomized Clinical Trial
Breast cancer is the most frequent malignancy in the female population Brazilian, except non-melanoma skin tumors. Surgery plays an important role in regional spot disease control and the definition of parameters for the adjuvant treatment indication. Surgical site infections (SSI) are defined as wound infections occur following invasive procedures, corresponding to 14-16% of all infections nosocomial in hospitalized patients, the most common among patients surgical. SSIs should be examined as potential wound contamination surgical, understood as the number of micro-organisms in the body and / or tissue being operated. Considering this aspect, the cancer surgery breast are classified by their potential for contamination by clean. The use of antibiotics to prevent the SSI in mastectomies is not standardized in Handbook of National Health Surveillance Agency due to the effectiveness of undocumented prophylaxis Thus the use of antibiotics may vary among services. So this randomized clinical trial to evaluate the influence of the use of Prophylactic antibiotics in SSI rates in oncological breast surgery.
KIND OF STUDY:
Primary, clinical, prospective, randomized, two-parallel-group, double-blind, controlled,
interventional, analytical. SAMPLE CALCULATION: based on proportions observed in a previous
study with and without antibiotic use in breast surgery (VEIGA-Filho, 2010) the number
calculated patients per group was 62, with a significance level of 5% and power 80% of the
test. SELECTION: will be selected in Mastology outpatient clinics 124 female patients to be
undergoing breast surgery for malignancy. The selection of patients will be divided in two
groups PLACEBO (N = 62): receive 0.9% saline 100 ml intravenously and CEFAZOLIN GROUP (N =
62): receive 2 g of cefazolin diluted in 0.9% saline by endovenous. In both groups will be
passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm
area determined by a field fenestrated sterile filter paper. Preoperatively will default
collection in the region higher interquadrantes breast to be operated immediately above
areolopapilar complex, which is not included in the designated area for collection. At end
surgery and also in the first postoperative day, the sterile field will be positioned with
fenestration on the wound. Tha material will be Standard microbiological methods used to
identify microoganismos. 0.2 ml aliquots of each sample are plated on agar media hypertonic
mannitol, selective for Staphylococcus sp, Sabouraud agar with chloramphenicol (0.05mg / ml),
selective for fungi, agar EMB Teague, selective for enterobacteria, and agar blood, for the
presence of hemolytic colonies. After 48 hours, the reading of the number of colony forming
units will be held by a microbiologist. Patients are regularly monitored for the occurrence
of infection, once a week for the first 30 days by a single surgeon. They will be used and
the definitions of surgical site infection classifications adopted by CDC
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