Antibiotic Prophylaxis in Oncological Surgery of Breast

NCT02809729 | Completed DMC

• 1 other identifier: MPRUBENS PRUDENCIO
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• surgical site infection in oncologic breast surgery

  To evaluate the influence of antibiotic prophylaxis in surgical site infection rates

  up to 30 days

Secondary Outcomes (1)

• cutaneous colonization in oncologic breast surgery

  intraoperative and the first postoperative day.

Study Arms (2)

placebo

PLACEBO COMPARATOR

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; Procedure: oncologic breast surgery; Other: Microbiology

cefazolin

ACTIVE COMPARATOR

The patients will receive 2 g of cefazolin diluted in 0.9% saline by endovenous at the start of anesthetic induction

Drug: Cefazolin; Procedure: oncologic breast surgery; Other: Microbiology

Interventions

Cefazolin DRUG

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

cefazolin

sterile saline DRUG

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

placebo

oncologic breast surgery PROCEDURE

The patient will be submitted to a conservative oncologic breast surgery

cefazolin; placebo

Microbiology OTHER

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.

cefazolin; placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fabiola Soares Moreira Campos: lead

Study Sites (1)

Universidade Do Vale Do Sapucai

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• FABIOLA SM CAMPOS, MD

  department of gynecology and obstetrics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of gynecology

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: June 22, 2016
• Study Start: January 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)