Antibiotic Prophylaxis in Oncological Surgery of Breast

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Wound Infection; Antibiotic Prophylaxis; Breast-Conserving Surgery
• Intervention / Treatment: Drug: sterile saline; Procedure: oncologic breast surgery; Other: Microbiology; Drug: Cefazolin

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

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Pouso Alegre, Minas Gerais, Brazil, 37550000
      • Universidade do Vale do Sapucai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• female patients who will undergo breast surgery for cancer evil, between 20 and 75 years, without any restriction as to ethnicity, education or social class;

Exclusion Criteria:

• Patients with BMI greater than 30 kgm 2;
• Patients undergoing neoadjuvant chemotherapy;
• Patients that will undergo immediate breast reconstruction procedures;
• Patients suffering from diabetes mellitus insulin-dependent;
• Patients classified as ASA III or higher
• Patients that postoperative antibiotic therapy have indication by another

clinical complication (cystitis, pneumonia, etc.);

-Patients to withdraw informed consent at any stage of the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; The patients will receive 0.9% saline for intravenous bottle with 100ml looks identical to the antibiotic at the start 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.
Active Comparator: cefazolin; The patients will receive 2 g of cefazolin diluted in 0.9% saline by endovenous at the start 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.; Drug: Cefazolin; 2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical site infection in oncologic breast surgery	To evaluate the influence of antibiotic prophylaxis in surgical site infection rates	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cutaneous colonization in oncologic breast surgery	To evaluate the microbiota that infects the skin in oncological breast surgery	intraoperative and the first postoperative day.

Collaborators and Investigators

• Sponsor: Fabiola Soares Moreira Campos
• Investigators: Study Chair: FABIOLA SM CAMPOS, MD, Department of Gynecology and Obstetrics

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 19, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: MPRUBENS PRUDENCIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO