Antibiotic Prophylaxis in Oncological Surgery of Breast

Sponsor

Fabiola Soares Moreira Campos (Other)

Overall Status

Completed

CT.gov ID

NCT02809729

Collaborator

(none)

124

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Breast-Conserving Surgery Wound Infection Antibiotic Prophylaxis	Drug: Cefazolin Drug: sterile saline Procedure: oncologic breast surgery Other: Microbiology	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Antibiotic Prophylaxis in Oncological Surgery of Breast: Randomized Clinical Trial

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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	Drug: Cefazolin 2 g of cefazolin diluted in 0.9% saline 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.

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

Drug: Cefazolin

2 g of cefazolin diluted in 0.9% saline 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

Outcome Measures

Primary Outcome Measures

surgical site infection in oncologic breast surgery [up to 30 days]
To evaluate the influence of antibiotic prophylaxis in surgical site infection rates

Secondary Outcome Measures

cutaneous colonization in oncologic breast surgery [intraoperative and the first postoperative day.]
To evaluate the microbiota that infects the skin in oncological breast surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Do Vale Do Sapucai	Pouso Alegre	Minas Gerais	Brazil	37550000

Sponsors and Collaborators

Fabiola Soares Moreira Campos

Investigators

Study Chair: FABIOLA SM CAMPOS, MD, department of gynecology and obstetrics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fabiola Soares Moreira Campos, Department of gynecology, Universidade do Vale do Sapucai

ClinicalTrials.gov Identifier:

NCT02809729

Other Study ID Numbers:

MPRUBENS PRUDENCIO

First Posted:

Jun 22, 2016

Last Update Posted:

Oct 25, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Wound Infection

Breast Neoplasms

Cefazolin

Study Results

No Results Posted as of Oct 25, 2017