Clinical trial · Interventional
Antibiotic Prophylaxis in Oncological Surgery of Breast
Antibiotic Prophylaxis in Oncological Surgery of Breast: Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic Prophylaxis | — | UNRESOLVED | — |
| Breast-Conserving Surgery | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cefazolin | Drug | — | UNRESOLVED |
| Microbiology | Other | — | UNRESOLVED |
| oncologic breast surgery | Procedure | — | UNRESOLVED |
| sterile saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- The patients will receive 0.9% saline for intravenous bottle with 100ml looks identical to the antibiotic at the start of anesthetic induction
- interventionNames
- Drug: sterile saline
- Procedure: oncologic breast surgery
- Other: Microbiology
- type
- ACTIVE_COMPARATOR
- label
- cefazolin
- description
- The patients will receive 2 g of cefazolin diluted in 0.9% saline by endovenous at the start of anesthetic induction
- interventionNames
- Drug: Cefazolin
- Procedure: oncologic breast surgery
- Other: Microbiology
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available