Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Number of patients with surgical site infection (SSI)
Study Overview
Brief Summary
Setting: Translacional Surgery Graduation Program - Universidade Federal de São Paulo and Hospital das Clínicas Samuel Libânio - Universidade do Vale do Sapucaí. Background: Breast reduction is one of the most performed plastic surgery procedures. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. Objective: To compare the influence of the use of prophylatic antibiotics as a single dose or for 24 hours on surgical site infection rates following reduction mammaplasty. Methods: Randomized trial of non-inferiority, with two parallel groups, double blinded. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to group A, that will receive antibiotics only at the anesthesia induction (n=73), or to group B, that will receive antibiotics at the anesthesia induction and for 24 hours (n=73). None of the patients will receive antibiotics after hospital discharge. Patients will be followed-up weekly, for 30 days, regarding surgical site infection. The Centers for Disease Control and Prevention criteria will be applied. A statistical analysis of the data will be performed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 and 60 years of age
- •body mass index (BMI) between 19 and 30 kg/m2
- •breast hypertrophy according to the criteria of Sacchini et al. and Franco and Rebello
Exclusion Criteria
- •patients who had previously undergone another surgical procedure of the breast
- •patients who have been diagnosed with a breast pathology
- •patients who had a child or breastfed within the last year
- •patients with uncontrolled comorbidities, such as arterial hypertension or diabetes
- •use of immunosuppressants
- •patients who had any infection during the follow-up period, requiring the use of antibiotics
- •patients who present any adverse effects due to the antibiotics during the study
- •patients who miss follow-up assessments
- •patients who withdraw their consent at any time
Arms & Interventions
Cephazolin
Patients will receive antibiotics (1g cephazolin) intravenously at the anesthestic induction and every 6 hours for 24 hours
Intervention: Cephazolin (Drug)
Sterile saline
Patients will receive antibiotics (cephazolin) only at the anesthesia induction, and sterile saline intravenously every 6 hours for 24 hours
Intervention: Sterile saline (Other)
Outcomes
Primary Outcomes
Number of patients with surgical site infection (SSI)
Time Frame: 30 days
Patients will be monitored for the occurrence of SSI once weekly during the first 30 days following hospital discharge by a single surgeon who is blinded to their treatment group. SSI will be evaluated based on the definition adopted by the Centers for Disease Control and Prevention.
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniela Francescato Veiga
Associate Professor
Federal University of São Paulo