Antibiotic Prophylaxis in Oncological Surgery of Breast
Condition: Breast Neoplasms; Breast-Conserving Surgery; Wound Infection; Antibiotic Prophylaxis
MeSH terms: Wound Infection; Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Cefazolin; sterile saline; oncologic breast surgery; Microbiology
Intervention type(s): Drug; Drug; Procedure; Other
Intervention description(s): 2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction; 0.9% saline sterile by endovenous, once, at the moment of anesthetic induction; The patient will be submitted to a conservative oncologic breast surgery; Samples for quantitative cultures will be obtained in the operating room before antisepsis and the end of surgery. A sample is also collected with the same patterning, on the first postoperative day, immediately after the removal of the dressing placed in the operating room. 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.
Intervention MeSH terms: Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention