An interventional study of Cephazolin and Sterile saline in Plastic Surgery, Mammaplasty and Anti-bacterial Agents, sponsored by Daniela Francescato Veiga. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Daniela Francescato Veiga · Not applicable, Interventional, and Prevention
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's enrollment of 146 is close to the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →Daniela Francescato Veiga is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive antibiotics (1g cephazolin) intravenously at the anesthestic induction and every 6 hours for 24 hours
Drug: Cephazolin
Patients will receive antibiotics (cephazolin) only at the anesthesia induction, and sterile saline intravenously every 6 hours for 24 hours
Other: Sterile saline
Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and postoperatively every 6 hours, for 24 hours.
Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and intravenous sterile saline postoperatively, every 6 hours, for 24 hours.
Number of patients with surgical site infection (SSI)
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.
Time frame: 30 days
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Daniela Francescato Veiga