Antibiotic Prophylaxis in Oncological Surgery of Breast
NCT ID: NCT02809729
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2015-01-31
2017-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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placebo
The patients will receive 0.9% saline for intravenous bottle with 100ml looks identical to the antibiotic at the start of anesthetic induction
sterile saline
0.9% saline sterile by endovenous, once, at the moment of anesthetic induction
oncologic breast surgery
The patient will be submitted to a conservative oncologic breast surgery
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.
cefazolin
The patients will receive 2 g of cefazolin diluted in 0.9% saline by endovenous at the start of anesthetic induction
Cefazolin
2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction
oncologic breast surgery
The patient will be submitted to a conservative oncologic breast surgery
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.
Interventions
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Cefazolin
2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction
sterile saline
0.9% saline sterile by endovenous, once, at the moment of anesthetic induction
oncologic breast surgery
The patient will be submitted to a conservative oncologic breast surgery
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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;
30 Years
75 Years
FEMALE
No
Sponsors
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Fabiola Soares Moreira Campos
OTHER
Responsible Party
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Fabiola Soares Moreira Campos
Department of gynecology
Principal Investigators
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FABIOLA SM CAMPOS, MD
Role: STUDY_CHAIR
department of gynecology and obstetrics
Locations
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Universidade Do Vale Do Sapucai
Pouso Alegre, Minas Gerais, Brazil
Countries
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Other Identifiers
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MPRUBENS PRUDENCIO
Identifier Type: -
Identifier Source: org_study_id