Antibiotic Prophylaxis in Oncological Surgery of Breast
Atslēgvārdi
Abstrakts
Apraksts
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
Datumi
Pēdējoreiz pārbaudīts: | 09/30/2017 |
Pirmais iesniegtais: | 06/18/2016 |
Paredzētā reģistrācija iesniegta: | 06/20/2016 |
Pirmais izlikts: | 06/21/2016 |
Pēdējais atjauninājums iesniegts: | 10/23/2017 |
Pēdējā atjaunināšana ievietota: | 10/24/2017 |
Faktiskais studiju sākuma datums: | 12/31/2014 |
Paredzamais primārās pabeigšanas datums: | 03/31/2017 |
Paredzamais pētījuma pabeigšanas datums: | 03/31/2017 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: cefazolin
Drug: placebo
Procedure: oncologic breast surgery
Other: Microbiology
Fāze
Roku grupas
Roka | Iejaukšanās / ārstēšana |
---|---|
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: placebo 0.9% saline sterile by endovenous, once, at the moment of anesthetic induction |
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 |
Atbilstības kritēriji
Vecums, kas piemērots studijām | 30 Years Uz 30 Years |
Dzimumi, kas ir piemēroti studijām | Female |
Pieņem veselīgus brīvprātīgos | Jā |
Kritēriji | 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; |
Rezultāts
Primārie rezultāti
1. surgical site infection in oncologic breast surgery [up to 30 days]
Sekundārie iznākuma mērījumi
1. cutaneous colonization in oncologic breast surgery [intraoperative and the first postoperative day.]