MedTrace Logo

Antibiotic Prophylaxis in Oncological Surgery of Breast

NCT02809729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2017-10-25

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms
  • Breast-Conserving Surgery
  • Wound Infection
  • Antibiotic Prophylaxis

Interventions

DRUG

Cefazolin

2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction

DRUG

sterile saline

0.9% saline sterile by endovenous, once, at the moment of anesthetic induction

PROCEDURE

oncologic breast surgery

The patient will be submitted to a conservative oncologic breast surgery

OTHER

Microbiology

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.

Sponsors & Collaborators

  • Fabiola Soares Moreira Campos

    lead OTHER

Principal Investigators

  • FABIOLA SM CAMPOS, MD · department of gynecology and obstetrics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02809729 on ClinicalTrials.gov